FDA Adverse Event
Injury
Summary report: N
1030489-2015-03386
MDR report key: 5293770
·
Received December 14, 2015
Report
- Report Number
- 1030489-2015-03386
- Event Type
- Injury
- Date Received
- December 14, 2015
- Report Date
- November 17, 2015
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWQ
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). NEITHER THE DEVICE 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 ON (B)(6) 2013, THE PATIENT UNDERWENT PLIF AT TH9-S1 (T9 RIGHT: HOOK, TH10-S1: PEDICLE SCREWS WERE INSERTED SEG MENTALLY). ON AN UNKNOWN DATE POST-OP, IT WAS FOUND THAT ROD AROUND L1 RIGHT WAS BROKEN. REVISION WAS PERFORMED ON (B)(6) 2015 IN WHICH ROD WAS EXPLANTED. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821865 | KWQ | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |