MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-07-03 for KERRISON DET130 DEG UP 1MM 180MMTHP FK906R manufactured by Aesculap Ag & Co. Kg.
[3682992]
Kerrison broke off at tip during acdf. Tip was found in pt. No pt injury or prolonging of surgery.
Patient Sequence No: 1, Text Type: D, B5
[10895357]
Eval: the instrument was microscopically checked. The breakage area of the broken foot plate followed a pattern known as "transcrystalline force fracture". The direction of breakage is to the right front. Any hints for a material or mfg issue could not be found. Based on the investigation results, this issue is likely related to handling influences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2013-00073 |
| MDR Report Key | 3234477 |
| Report Source | 01,07 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-06-27 |
| Date of Event | 2013-04-12 |
| Date Mfgr Received | 2013-05-08 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2013-09-30 |
| 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 & 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 DET130 DEG UP 1MM 180MMTHP |
| Product Code | GXJ |
| Date Received | 2013-07-03 |
| Model Number | FK906R |
| Catalog Number | FK906R |
| ID Number | FK906R-B00BW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN DE 78532 DE 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-03 |