FDA Adverse Event
Injury
Summary report: N
STABILITY PIN RET BLADE
MDR report key: 4723649
·
Received April 23, 2015
Report
- Report Number
- 1030489-2015-00844
- Event Type
- Injury
- Date Received
- April 23, 2015
- Date of Event
- April 21, 2015
- Report Date
- April 21, 2015
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- GAD
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE STABILITY PIN BROKE OFF AND REMAINED IN THE "VERTEBRA (BONE STRUCTURE) OF THE PATIENT." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270026 | STABILITY PIN RET BLADE | RETRACTOR | GAD | MEDTRONIC SOFAMOR DANEK USA, INC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |