MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2015-01-16 for ADD-ON CONDYLE N/A 01-2692 manufactured by Biomet Microfixation.
[18030084]
The distributor reported a revision due to the fracture of the recon plate. The date of the revision surgery has not been provided. The surgeon has requested a custom plate, as this is the third standard reconstruction plate that this patient has broken over the last 15 years. The surgeon feels a stronger plate is needed or he needs to do a bone graft, which the patient does not want to do.
Patient Sequence No: 1, Text Type: D, B5
[18317588]
Without a product return, no product evaluation is able to be conducted. The lot history of the implanted unit is unknown; therefore, the device history records are unable to be reviewed. The warnings in the package insert state this type of event can occur. The user facility is foreign; therefore, a facility medwatch report will not be available. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. File three of four for the same event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2015-00016 |
| MDR Report Key | 4427324 |
| Report Source | 01,05,08 |
| Date Received | 2015-01-16 |
| Date of Report | 2014-12-22 |
| Date Mfgr Received | 2014-12-22 |
| Date Added to Maude | 2015-01-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. MICHELLE COLDWATER |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADD-ON CONDYLE |
| Generic Name | RECON ADD-ON CONDYLE RIGHT |
| Product Code | NEI |
| Date Received | 2015-01-16 |
| Model Number | N/A |
| Catalog Number | 01-2692 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-01-16 |