MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-24 for OSTEOTOME manufactured by .
[2832745]
Medwatch form reported that a piece of the osteotome broke off when it hit the staple. Additional information provided in a phone conversation explained that the product code is not available. The device was discarded and there was no harm, physical or otherwise to the patient as the broken piece was visual and retrieved. No delay in the procedure was reported.
Patient Sequence No: 1, Text Type: D, B5
[10047938]
It has been communicated that the device and/or lot information is not available for evaluation. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed. (b)(4): device was discarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2012-00356 |
| MDR Report Key | 2666776 |
| Report Source | 05,06 |
| Date Received | 2012-07-24 |
| Report Date | 2012-06-25 |
| Date Reported to Mfgr | 2012-06-25 |
| Date Mfgr Received | 2012-06-25 |
| Date Added to Maude | 2012-11-14 |
| 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 | MR MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEOTOME |
| Generic Name | OSTEOTOME |
| Product Code | KDG |
| Date Received | 2012-07-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-24 |