FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
MDR report key: 3071247
·
Received April 22, 2013
Report
- Report Number
- 1030489-2013-01186
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 15, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(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 BROKE ON TWO SCREW DRIVERS. BOTH BROKEN TIPS WERE ABLE TO BE RETRIEVED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172692 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |