Spinopelvic Fixation Using an Osseointegrative Implant: Analysis of Postmarket Surveillance to Determine the Failure Rate

Article Figures & Data

Table 1

Breakdown of pelvic fixation configurations of the osseointegrative implant.

Pelvic Fixation Configuration	Count	Reported Complaints, n (%)
Single osseointegrative implant	4381	1 (0.02)
2+ osseointegrative implants	1110	38 (3.40)
Osseointegrative implant + additional fusion device	1394	13 (1.35)
Trauma fixation	22	-

Table 2

Listing of implant-related complaints.

Complaint	Count	Days to Event, Mean (SD)	Procedural Complaint Rate, % (N = 6907)
Set screw disassociation	23	133.0 (102.2)	0.33
Implant loosening	10	375.6 (103.1)	0.15
Infection (unrelated to implant)	8	215.4 (107.7)	0.12
Implant sleeve separation	5	116.8 (163.4)	0.07
Lucency/halos	4	414.0 (222.7)	0.06
Malpositioned implant	2	178.5 (212.8)	0.03

Table 3

Indications for early and late surgical revisions.

Indication	Early Revisions		Late Revisions
Indication	Count	Days to Event, Mean (SD)	Count	Days to Event, Mean (SD)
Lucency/haloing	0	-	3	487.7 (163.4)
Set screw dissociation	8	47.9 (14.3)	11	199.3 (103.1)
Implant loosening	0	-	10	375.6 (103.1)
Malpositioned (asymptomatic)	1	28.0 (0.0)	1	329.0 (0.0)
Infection (unrelated to implant)	1	90.0 (0.0)	6	375.6 (103.1)
Total	10	50.1 (19.9)	31	299.5 (140.9)