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 PM619803 manufactured by Biomet Microfixation.
[91898476]
Udi# (b)(4). A photograph of the implant in a bag was provided, however the whole implant is not visible. Unable to determine the part numbers of the screws and plates used to fixate the implant in the photograph. Review of device history records show the lot released with no recorded anomaly or deviation. The warnings in the package insert state this type of event can occur. Without a product return, no product evaluation is able to be conducted. 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
[91898477]
The distributor reported the first choice cranioplasty implant crumbled during implantation. The back-up implant was used to complete the surgery. It is reported there was a longer delay, however the duration is unknown. Additional information was requested but has not been received at this time.
Patient Sequence No: 1, Text Type: D, B5
[117311369]
This follow-up report is being submitted to relay additional information. The following sections were updated: date of this report, describe event or problem, date received by manufacturer, type of report and follow-up number, follow-up type, additional narratives/data.
Patient Sequence No: 1, Text Type: N, H10
[117311370]
It was reported the implant was not pre-drilled and broke while screws were being inserted. The surgical delay was twenty minutes. No foreign body remained in the patient. The product information for the plates and screws remains unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00797 |
| MDR Report Key | 7025203 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-13 |
| Date of Report | 2018-04-26 |
| Date of Event | 2017-10-12 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2017-08-17 |
| 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 |
| Returned To Mfg | 2018-04-11 |
| Model Number | N/A |
| Catalog Number | PM619803 |
| Lot Number | 777060 |
| ID Number | SEE H10 NARRATIVE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-11-13 |