MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-07-16 for KERRISON 15MM JAW40DG-UP4MM203MM FF745R manufactured by Aesculap, Inc..
[435125]
The screw on the kerrison loosened during use and fell into the wound of a pt. X-ray taken to locate and retrieve broken piece. Surgery prolonged 20 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2005-00035 |
| MDR Report Key | 624085 |
| Report Source | 07 |
| Date Received | 2005-07-16 |
| Date of Report | 2005-06-29 |
| Date of Event | 2005-06-01 |
| Date Mfgr Received | 2005-06-15 |
| Date Added to Maude | 2005-08-04 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DEE SCHLUETER |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| Manufacturer G1 | S.UA. MARTIN GMBH & CO. KG |
| Manufacturer Street | UHLANDSTRASSE 17 |
| Manufacturer City | TUTTLINGEN 78604 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERRISON 15MM JAW40DG-UP4MM203MM |
| Generic Name | RONGEUR |
| Product Code | GXJ |
| Date Received | 2005-07-16 |
| Model Number | NA |
| Catalog Number | FF745R |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 613736 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US |
| Baseline Brand Name | KERRISON15MM JAW40DG-UP4MM203 |
| Baseline Generic Name | PUNCH, SKULL |
| Baseline Model No | NA |
| Baseline Catalog No | FF745R |
| Baseline ID | NA |
| Baseline Device Family | RONGEUR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-16 |