MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-06 for KERRISON DETACH 130DG UP 200MM FL961B FK961B manufactured by Aesculap Ag And Co. Kg.
[5035862]
During cervical spine procedure, the kerrison tip broke off. Surgical delay of 5 minutes. Pt was not affected. No add'l tests were performed.
Patient Sequence No: 1, Text Type: D, B5
[12483467]
Mfg site eval: eval on-going.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00780 |
| MDR Report Key | 4213912 |
| Report Source | 07 |
| Date Received | 2014-10-06 |
| Date of Report | 2014-10-06 |
| Date Mfgr Received | 2014-09-05 |
| Date Added to Maude | 2014-11-03 |
| 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 DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG AND CO KG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGNE 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 DETACH 130DG UP 200MM |
| Generic Name | BONE PUNCH |
| Product Code | GXJ |
| Date Received | 2014-10-06 |
| Model Number | FL961B |
| Catalog Number | FK961B |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG AND CO. KG |
| Manufacturer Address | TUTTLINGEN, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-06 |