MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2003-09-24 for ABC SCREW REMOVAL INSTRUMENT FJ829R-DEVICE 1 manufactured by Aesculap Ag & Co. Kg.
[304156]
During an anterior cervical dissectomy with fusion, two screw removal instruments and two screwdrivers broke. The pieces were retrieved and discarded. The user/facility did not have any other instruments to complete the case. The patient was closed. Instruments were brought in the next day and the patient was reopened to complete the surgery. The patient did not suffer any complications as a result of the alleged failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2003-00034 |
| MDR Report Key | 485544 |
| Report Source | 05,06,07 |
| Date Received | 2003-09-24 |
| Date of Report | 2003-09-24 |
| Date of Event | 2003-07-02 |
| Date Mfgr Received | 2003-09-19 |
| Date Added to Maude | 2003-09-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATHY RACOSKY |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABC SCREW REMOVAL INSTRUMENT |
| Generic Name | SCREW REMOVAL INSTRUMENT |
| Product Code | HXY |
| Date Received | 2003-09-24 |
| Model Number | NA |
| Catalog Number | FJ829R-DEVICE 1 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 474429 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | P.O. BOX 40 TUTTLINGEN GM 78501 |
| Baseline Brand Name | ABC SCREW REMOVAL INSTRUMENT |
| Baseline Generic Name | SCREW REMOVAL INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | FJ829R-DEVICE 1 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-24 |