FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1881247
·
Received October 6, 2010
Report
- Report Number
- 1030489-2010-01299
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Date of Event
- September 11, 2010
- Report Date
- September 17, 2010
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION, AND DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN DURING USE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | PITUITARY | LXH | MEDTRONIC SOFAMOR DANEK | NA | GZ06H056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |