FDA Adverse Event
Injury
Summary report: N
NOVEL-SD, MEDIUM, 9MM, PEEK
MDR report key: 1651410
·
Received March 31, 2010
Report
- Report Number
- 2027467-2010-00007
- Event Type
- Injury
- Date Received
- March 31, 2010
- Date of Event
- March 23, 2010
- Report Date
- March 23, 2010
- Manufacturer
- ALPHATEC SPINE, INC.
- Product Code
- MQP
- PMA / PMN Number
- K050553
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (6). THE DESIGN OF THE NOVEL PEEK CAGE USED IN CONJUNCTION WITH THE PROVIDED SURGICAL TECHNIQUE WOULD REDUCE THE RISK OF THIS TYPE OF OCCURRENCE. A REVIEW OF THE TREND DATA FOR THE PAST 5 YEARS REVEALED NO OTHER COMPLAINTS OF THIS NATURE REPORTED.
Description of Event or Problem · 1
ON (B) (6) 2010 - REVISION SURGERY TO REMOVE A PEEK CAGE THAT SURGEON BELIEVES BACKED OUT OF LOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVEL-SD, MEDIUM, 9MM, PEEK | MQP | ALPHATEC SPINE, INC. | 64815-009 | 628302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |