MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-13 for HTR-PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM619806 manufactured by Biomet Microfixation.
[91901155]
(b)(4). It is reported the device will not be returned for evaluation as it was implanted in the patient. The device history records were reviewed and no non-conformance was identified that would cause or contribute to the reported event. 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.
Patient Sequence No: 1, Text Type: N, H10
[91901156]
It is reported the cranioplasty implant did not fit, the surgery lasted almost 5 hours. Additional information was requested but has not been received at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00801 |
| MDR Report Key | 7025202 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-13 |
| Date of Report | 2018-04-06 |
| Date of Event | 2017-10-12 |
| Date Mfgr Received | 2018-03-30 |
| Device Manufacturer Date | 2017-08-31 |
| Date Added to Maude | 2017-11-13 |
| 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 | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| 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 | HTR-PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT |
| Generic Name | HARD TISSUE REPLACEMENT - PATIENT MATCHED IMPLANT |
| Product Code | KKY |
| Date Received | 2017-11-13 |
| Model Number | N/A |
| Catalog Number | PM619806 |
| Lot Number | 778220 |
| ID Number | SEE H10 NARRATIVE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-11-13 |