MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-10 for HTR-PMI BUCKLEY RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM620870 manufactured by Biomet Microfixation.
[186366439]
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. The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing. 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
[186366440]
It was reported the patient had a protrusion in the frontal cranial area following implantation of a custom cranial implant. It is planned that the custom cranial implant will be removed and replaced with a newly designed custom cranial implant. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00098 |
| MDR Report Key | 9689596 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-10-22 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2020-02-10 |
| 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 BUCKLEY RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT |
| Generic Name | CUSTOM MADE DEVICE |
| Product Code | FWP |
| Date Received | 2020-02-10 |
| Model Number | N/A |
| Catalog Number | PM620870 |
| Lot Number | 838560 |
| 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; 2. Required No Informationntervention | 2020-02-10 |