FDA Adverse Event
Injury
Summary report: N
TSRH SPINAL SYSTEM
MDR report key: 5433105
·
Received February 12, 2016
Report
- Report Number
- 1030489-2016-00476
- Event Type
- Injury
- Date Received
- February 12, 2016
- Report Date
- January 20, 2016
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- KWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 828-083, 510K # K880215 WAS CLEARED IN THE UNITED STATES. NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT UNSPECIFIED SPINAL PROCEDURE FOR KYPHOSIS AT TH4-ILIAC1 ON (B)(6) 2012. ON (B)(6) 2016, ROD BREAKAGE WAS OBSERVED. REVISION SURGERY WAS PERFORMED TO REPLACE ROD AND SCREW ON (B)(6) 2016. NO FRAGMENT OF THE PRODUCT REMAINED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90126 | TSRH SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDICS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Required Intervention |