FDA Adverse Event
Injury
Summary report: N
TSRH SPINAL SYSTEM
MDR report key: 6123615
·
Received November 23, 2016
Report
- Report Number
- 1030489-2016-03227
- Event Type
- Injury
- Date Received
- November 23, 2016
- Report Date
- November 8, 2016
- 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
DATE OF EXPLANT IS UNKNOWN BUR SURGERY HAPPENED IN (B)(6) 2016. THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG NO. 811-407 AND 510K# K982990 ((B)(4)) IS APPROVED IN US. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE CANNOT DETERMINE DEFINITIVE CAUSE OF EVENT.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT WITH TH7 HEMIVERTEBRA UNDERWENT TH7 OSTEOTOMY AND ONE ABOVE AND ONE BELOW FIXATION AT TH6-8 ON (B)(6) 2016.ON AN UNKNOWN DATE, POST-OP, THE PATIENT DEVELOPED INFECTION. HENCE, A REVISION SURGERY WAS PERFORMED IN WHICH THE RELEVANT IMPLANT WAS REMOVED. THERE WAS NO COMPLICATION AS A RESULT OF THIS REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775044 | TSRH SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDICS | NA | 0389635W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |