FDA Adverse Event
Injury
Summary report: N
CUSTOM IMPLANT TRIAL, 14MM, 0, SS
MDR report key: 3177492
·
Received June 19, 2013
Report
- Report Number
- 2027467-2013-00016
- Event Type
- Injury
- Date Received
- June 19, 2013
- Date of Event
- May 22, 2013
- Report Date
- June 3, 2013
- Manufacturer
- ALPHATEC SPINE INC
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE CUSTOM MANUFACTURED INSTRUMENT FOUND THAT THE TIP TO SHAFT WELD APPEARED TO BE BRITTLE POSSIBLY DUE TO IMPROPER ANNEALING. COMPLETE DETAILS ATTACHED IN SUMMARY REPORT.
Description of Event or Problem · 1
THE DISTAL TIP OF A CUSTOM 14MM IMPLANT TRIAL FRACTURED AND BECAME SEPARATED FROM THE INSTRUMENT DURING A GLIF SURGICAL CASE ON (B)(6) 2013. THE DETACHED SECTION BECAME WEDGED BETWEEN THE L4 AND L5 VERTEBRAL BODIES. SURGERY WAS EXTENDED APPROXIMATELY 45 MINUTES IN ORDER TO ATTACH A SLAP HAMMER AND REMOVE THE TRIAL TIP FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278637 | CUSTOM IMPLANT TRIAL, 14MM, 0, SS | LXH | LXH | ALPHATEC SPINE INC | C20931-014-C01 | C-5689 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |