FDA Adverse Event
Injury
Summary report: N
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
MDR report key: 3962593
·
Received July 14, 2014
Report
- Report Number
- 3008875054-2014-00006
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- June 16, 2014
- Report Date
- July 15, 2014
- Manufacturer
- ZYGA TECHNOLOGY, INC.
- Product Code
- OUR
- PMA / PMN Number
- K130092
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT LABELING INCLUDES RISKS ASSOCIATED WITH IMPLANT SIZE SELECTION.
Description of Event or Problem · 1
PATIENT HAD BILATERAL SACROILIAC FUSIONS PLACING SYMMETRY IMPLANTS ON (B)(6) 2014. THE 70MM IMPLANT WAS PLACED INTO THE RIGHT SACRAL FORAMEN. PATIENT REPORTED RIGHT RADICULAR PAIN IMMEDIATELY POST-OP. THE SURGEON MADE THE DECISION TO REVISE BY REMOVING THE 12.5MMX70XX IMPLANT AND REPLACING WITH ANOTHER IMPLANT OF SHORTER LENGTH. REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. THE 12.5X70MM IMPLANT WAS REMOVED AND REPLACED WITH A 12.5X50MM IMPLANT. ON (B)(6) 2014 THE SURGEON FOLLOWED-UP INDICATING THE PATIENT IS DOING OKAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409791 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | SACROILIAC JOINT FIXATION | OUR | ZYGA TECHNOLOGY, INC. | 10-P12570-01 | 110573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |