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 2019-04-25 for 8374/19 LEFT FRONTAL PARIETAL TEMPORAL IMPLANT N/A PM621847 manufactured by Biomet Microfixation.
[143122537]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. The user facility is foreign; therefore a facility medwatch report will not be available. Event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[143122538]
It was reported that the implant was too small and did not fit the patient's cranial defect. The procedure was delayed more than an hour and finished with an implant made of bone cement instead of the planned implant. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00247 |
| MDR Report Key | 8551834 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-25 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-07-24 |
| Device Manufacturer Date | 2019-03-19 |
| Date Added to Maude | 2019-04-25 |
| 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. MERRIANNE CASSIDY |
| 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 | 8374/19 LEFT FRONTAL PARIETAL TEMPORAL IMPLANT |
| Generic Name | MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCT |
| Product Code | KKY |
| Date Received | 2019-04-25 |
| Model Number | N/A |
| Catalog Number | PM621847 |
| Lot Number | 894470 |
| 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. Required No Informationntervention | 2019-04-25 |