FDA Adverse Event
Malfunction
Summary report: N
NOVEL LUMBAR INSERTER ASSEMBLY (STAINLESS STEEL)
MDR report key: 4918861
·
Received July 16, 2015
Report
- Report Number
- 2027467-2015-00144
- Event Type
- Malfunction
- Date Received
- July 16, 2015
- Date of Event
- May 22, 2013
- Report Date
- June 12, 2015
- Manufacturer
- ALPHATEC SPINE INC
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE INSTRUMENT WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. ADDITIONAL INFORMATION PROVIDED BY THE SALES REP REVEALED THE SURGEON IS BREAKING THE INSERTERS WHEN HE IS REMOVING THE TRIAL, INSTEAD OF USING THE SLAP HAMMER. HE MOVES THE INSTRUMENT BACK AND FORTH UNTIL THE TRIAL CAN BE PULLED OUT.
Description of Event or Problem · 1
THE TIP OF THE INSTRUMENT BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464515 | NOVEL LUMBAR INSERTER ASSEMBLY (STAINLESS STEEL) | LXH | LXH | ALPHATEC SPINE INC | 64920 | 6820701R1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |