FDA Adverse Event
Injury
Summary report: N
VIS PÉDICULAIRE POLYAXIALE Ø5,5 LG40
MDR report key: 5614592
·
Received April 28, 2016
Report
- Report Number
- 3003853072-2016-00036
- Event Type
- Injury
- Date Received
- April 28, 2016
- Date of Event
- November 17, 2015
- Manufacturer
- ZIMMER SPINE
- Product Code
- NKB
- PMA / PMN Number
- PK111301
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LOT NUMBER WAS CORRECTED FROM H23491E TO H23516C.
Additional Manufacturer Narrative · 1
BASED ON THE REPORTED COMPLAINT AND VISUAL EVALUATION OF THE RETURNED DEVICE, NO ADDITIONAL EVALUATION WILL BE PERFORMED AS THERE IS NO REPORTED FAILURE OF THIS DEVICE OR VISUAL DAMAGE IDENTIFIED. REPORT FOUR OF FOUR FOR THE SAME EVENT, REFERENCE 3003853072-2015-00016-3, 3003853072-2016-00011-1, AND 3003853072-2016-00012-1. THIS REPORT WAS COMPLETED BASED ON THE RECEIPT OF A LOT NUMBER WHICH WAS NOT REPORTED.
Description of Event or Problem · 1
IT IS REPORTED THAT ON (B)(6) 2015 IT WAS DISCOVERED THAT THE LEFT SACRAL SCREW WAS FRACTURED. THE PATIENT REQUIRED REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272486 | VIS PÉDICULAIRE POLYAXIALE Ø5,5 LG40 | PEDICLE SCREW | NKB | ZIMMER SPINE | N/A | H23516C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| R |