MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-09 for HTR PMI MA 1967-20191022 RIGHT FRONTAL TEMPORAL PARIETAL IMPLANT N/A PM622638 manufactured by Biomet Microfixation.
[174482491]
Zimmer biomet complaint (b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. It is unknown at this time if the device will be returned for evaluation; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. The user facility is foreign; therefore a facility medwatch report will not be available. Report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[174482492]
It was reported an incorrectly designed custom cranioplasty implant was discovered during surgery. The defect on the skull was on the left side and the implant was produced for the right side. Initial reports indicate that the incorrect scans were used in the design process. The surgery was completed using cement which resulted an unspecified delay. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00039 |
| MDR Report Key | 9569693 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2019-11-12 |
| Date Added to Maude | 2020-01-09 |
| 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. JENNIFER DELANEY |
| 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 MA 1967-20191022 RIGHT FRONTAL TEMPORAL PARIETAL IMPLANT |
| Generic Name | CUSTOM DEVICE |
| Product Code | KKY |
| Date Received | 2020-01-09 |
| Model Number | N/A |
| Catalog Number | PM622638 |
| Lot Number | 945690 |
| 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 | 2020-01-09 |