FDA Adverse Event
Malfunction
Summary report: N
METRX
MDR report key: 3113447
·
Received May 15, 2013
Report
- Report Number
- 1030489-2013-01701
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 15, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). THE INSTRUMENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MICRO PITUITARY TIP IS BROKEN AND WILL NOT MAKE CUTS DURING AN UNSPECIFIED SPINAL SURGERY. NO FRAGMENTS WERE LEFT IN PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214073 | METRX | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |