MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-03-20 for KERRISON 130DG-UP 5MM 180MM FF722R manufactured by Aesculap Ag & Co. Kg.
[4616902]
Country of complaint: (b)(6). Kerrison footplate broke during a surgery and was not cutting as expected.
Patient Sequence No: 1, Text Type: D, B5
[12015044]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00192 |
| MDR Report Key | 3850741 |
| Report Source | 01,07 |
| Date Received | 2014-03-20 |
| Date of Report | 2014-03-20 |
| Date of Event | 2014-01-08 |
| Date Mfgr Received | 2014-01-11 |
| Date Added to Maude | 2014-06-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG & CO. KG |
| Manufacturer Street | P.O. BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERRISON 130DG-UP 5MM 180MM |
| Generic Name | BONE PUNCH |
| Product Code | GXJ |
| Date Received | 2014-03-20 |
| Model Number | FF722R |
| Catalog Number | FF722R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-03-20 |