FDA Adverse Event
Malfunction
Summary report: N
METRX
MDR report key: 2973595
·
Received February 22, 2013
Report
- Report Number
- 1030489-2013-00595
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- December 12, 2012
- Report Date
- January 24, 2013
- Manufacturer
- MSD BARTLETT MFG
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE TIP OF THE MICROPITUITARY IS BROKEN AT THE LOCKING PIN AND THE CAUSE OF THE EVENT IS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MICROPITUITARY TIP WAS BENT IN AN UNKNOWN SPINAL PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78329 | METRX | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MSD BARTLETT MFG | NA | GZ06H057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |