FDA Adverse Event
Injury
Summary report: N
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
MDR report key: 2850352
·
Received November 29, 2012
Report
- Report Number
- 2530088-2012-01030
- Event Type
- Injury
- Date Received
- November 29, 2012
- Report Date
- November 2, 2012
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- NKB
- PMA / PMN Number
- K100952
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL NARRATIVE: INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
A HOSPITAL IN (B)(6) REPORTS A PATIENT IMPLANTED WITH A MATRIX CONSTRUCT IS EXPERIENCED AN ALLERGIC REACTION ON THE UPPER SECTION OF L3 ON BOTH SIDES. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM | PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM | NKB | SYNTHES BRANDYWINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SCREW |