FDA Adverse Event
Injury
Summary report: N
VERTEX RECONSTRUCTION SYSTEM
MDR report key: 7141871
·
Received December 22, 2017
Report
- Report Number
- 1030489-2017-02554
- Event Type
- Injury
- Date Received
- December 22, 2017
- Report Date
- December 22, 2017
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- KWP
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7752536, 510K # K082728 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT DECOMPRESSION AND FIXATION AT C6-T3. POST-OP, INFECTION WAS DEVELOPED. HENCE, A REVISION SURGERY WAS PERFORMED FOR DEBRIDEMENT AND WASHING; CEMENT WAS IMPLANTED THEREAFTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 921693 | VERTEX RECONSTRUCTION SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDICS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |