MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-06 for KERRISON DETACH 130DG UP 200MM 1MM THIN FK961B manufactured by Aesculap Ag & Co. Kg.
[4403922]
Decompression surgery: tip broke during spinal surgery in thin bone. No pt injury or prolonging of surgery reported. Footplate is completely broken from the device. Footplate was discarded. Piece was able to be easily removed. Momentary delay. No add'l x-ray was taken in order to locate the broken piece.
Patient Sequence No: 1, Text Type: D, B5
[11898360]
Eval: eval on-going.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00340 |
| MDR Report Key | 3829813 |
| Report Source | 07 |
| Date Received | 2014-05-06 |
| Date of Report | 2014-05-06 |
| Date of Event | 2014-04-07 |
| Date Mfgr Received | 2014-04-16 |
| Date Added to Maude | 2014-06-12 |
| 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 | 3 |
| 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 | PO 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 DETACH 130DG UP 200MM 1MM THIN |
| Generic Name | BONE PUNCH |
| Product Code | GXJ |
| Date Received | 2014-05-06 |
| Model Number | FK961B |
| Catalog Number | FK961B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-06 |