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 2004-08-13 for ABC SCREW REMOVAL INSTRUMENT FJ829 manufactured by Aesculap Ag & Co. Kg.
[426812]
During an abc removal case, a screw would not come out. Surgeon tried using the locking instrument (fj828r - device2) to remove the locking screw and the instrument broke, after the screw was free, spinning surgeon tried the extraction instrument (fj829r - device 1). It broke as well. All pieces were retrieved. The pt did not suffer any complications as a result of the alleged failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2004-00029 |
| MDR Report Key | 618832 |
| Report Source | 05,06,07 |
| Date Received | 2004-08-13 |
| Date of Report | 2004-08-12 |
| Date of Event | 2004-06-29 |
| Date Mfgr Received | 2004-07-30 |
| Date Added to Maude | 2005-07-05 |
| 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 | 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 | 2004-08-13 |
| Returned To Mfg | 2004-08-10 |
| Model Number | NA |
| Catalog Number | FJ829 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 608512 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | P.O. BOX 40 TUTLINGEN GM 78501 |
| Baseline Brand Name | ABC SCREW REMOVAL INSTRUMENT |
| Baseline Generic Name | SCREW REMOVAL INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | FJ829 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-08-13 |