FDA Adverse Event
Malfunction
Summary report: N
KERRISON BLK COATED 130 UP 180X3MM REG
MDR report key: 3786513
·
Received March 21, 2014
Report
- Report Number
- 2916714-2014-00203
- Event Type
- Malfunction
- Date Received
- March 21, 2014
- Date of Event
- January 21, 2014
- Report Date
- March 21, 2014
- Manufacturer
- AESCULAP AG & CO. KG
- Product Code
- GXJ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MFG SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). INSTRUMENT BROKEN AT THE JAW. THE INSTRUMENT BROKE DURING AN OPERATION. THE PIECE OF THE INSTRUMENT THAT BROKE IS APPROXIMATELY 5 MM AND FELL IN THE PT. THE PIECE WAS RETRIEVED WITH NO EXTENSION OF SURGICAL TIME. NO CLINICAL CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 169190 | KERRISON BLK COATED 130 UP 180X3MM REG | BONE PUNCH | GXJ | AESCULAP AG & CO. KG | FK902B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |