FDA Adverse Event
Malfunction
Summary report: N
KERRISON 130DG-UP 5MM 180MM
MDR report key: 3850741
·
Received March 20, 2014
Report
- Report Number
- 2916714-2014-00192
- Event Type
- Malfunction
- Date Received
- March 20, 2014
- Date of Event
- January 8, 2014
- Report Date
- March 20, 2014
- Manufacturer
- AESCULAP AG & CO. KG
- Product Code
- GXJ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON (B)(6) 2014. MANUFACTURING SITE EVALUATION: MULTIPLE ATTEMPTS HAVE BEEN MADE REQUESTING ADDITIONAL INFORMATION AND RETURN OF DEVICE FOR EVALUATION. NO RESPONSE HAS BEEN RECEIVED.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). KERRISON FOOTPLATE BROKE DURING A SURGERY AND WAS NOT CUTTING AS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166758 | KERRISON 130DG-UP 5MM 180MM | BONE PUNCH | GXJ | AESCULAP AG & CO. KG | FF722R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |