FDA Adverse Event
Injury
Summary report: N
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
MDR report key: 3962616
·
Received July 15, 2014
Report
- Report Number
- 3008875054-2014-00008
- Event Type
- Injury
- Date Received
- July 15, 2014
- Date of Event
- January 15, 2014
- Report Date
- July 16, 2014
- Manufacturer
- ZYGA TECHNOLOGY INC.
- Product Code
- OUR
- PMA / PMN Number
- K130092
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT HAD TWO IMPLANTS REMOVED; THE OTHER IMPLANT IS REPORTED UNDER MFR. REPORT #3008875054-2014-00007.
Description of Event or Problem · 1
PATIENT UNDERWENT SACROILIAC FUSION USING SIMMETRY IMPLANTS ON (B)(6) 2014 AND DID NOT RETURN TO THE SURGEONS OFFICE FOR OVER 4 MONTHS. UPON SEEING THE SURGEON THE PATIENT REPORTED HAVING EXPERIENCED IMMEDIATE POST-OP PAIN AND DEMANDED TO HAVE THE IMPLANTS REMOVED. THE SURGEON REMOVED THE IMPLANTS ON (B)(6) 2014 AND PLACED A MANUFACTURED ALLOGRAFT INTO THE JOINT USING A POSTERIOR APPROACH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412264 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | SACROILIAC JOINT FIXATION | OUR | ZYGA TECHNOLOGY INC. | 10-S06570-01 | 110568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |