MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-06-07 for MICROCHOICE INTRA ORAL BLADE 11.5X7 X 4MM 00502310100 manufactured by Conmed Linvatec.
[669865]
It was reported that during use of this blade in an intraoral vertical ramus osteotomy, the blade broke in the patient's bone and was retrieved. There was no injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[7979956]
Investigation findings: the blade was received for evaluation without the detached portion. A visual inspection confirmed the reported problem and found the blade broke off at the shaft weld. The investigation was unable to determine a cause for this failure. A review of product history for the past 2 years shows one similar reported problem. No injuries are associated with this failure mode. Conmed linvatec will continue to monitor this product for failures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2007-00313 |
| MDR Report Key | 863645 |
| Report Source | 06 |
| Date Received | 2007-06-07 |
| Date of Report | 2007-05-10 |
| Date of Event | 2007-05-10 |
| Date Mfgr Received | 2007-05-10 |
| Device Manufacturer Date | 2006-11-02 |
| Date Added to Maude | 2007-07-16 |
| 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 | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33733 |
| Manufacturer Country | US |
| Manufacturer Postal | 33733 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROCHOICE INTRA ORAL BLADE 11.5X7 X 4MM |
| Generic Name | STERILE BLADE |
| Product Code | DZH |
| Date Received | 2007-06-07 |
| Returned To Mfg | 2007-05-23 |
| Model Number | NA |
| Catalog Number | 00502310100 |
| Lot Number | BBC78398 |
| ID Number | NA |
| Device Expiration Date | 2011-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 858864 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-07 |