FDA Adverse Event
Injury
Summary report: N
CLOSURE TOP
MDR report key: 4908235
·
Received July 9, 2015
Report
- Report Number
- 2184052-2015-00065
- Event Type
- Injury
- Date Received
- July 9, 2015
- Report Date
- June 12, 2015
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- KWP
- PMA / PMN Number
- K133556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THUS, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. REVIEW OF ALL PROVIDED INFORMATION CONCLUDED THAT THERE IS NO EVIDENCE OF A PRODUCT DEFECT OR DEFICIENCY. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY IS SCHEDULED TO REMOVE BACKED OUT VIRAGE CLOSURE TOPS AND BROKEN TRANSITION RODS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447108 | CLOSURE TOP | CLOSURE TOP | KWP | ZIMMER SPINE, INC. | 07.01728.001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |