MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-07-12 for HARD TISSUE REPLACEMENT-PATIENT MATCHED LEFT FRONTAL SPHENOID PARIETAL TEMPORAL N/A PM619381 manufactured by Biomet Microfixation.
[79810764]
(b)(4). The user facility is foreign; therefore a facility medwatch report will not be available. The device history record was 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 device remains implanted, at this time no product will be returned to the manufacturer for evaluation. 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
[79810765]
It is reported the implant was soaked in genta and nacl for a few minutes, approximately 2-3 minutes two times. The implant was inspected prior to implantation and no issues were noted. When the surgeon attempted to insert a screw approximately 7-10 mm from the edge of the implant it broke. The surgeon did not pre-drill prior to inserting the screw. The patient did not retain any broken fragments of the implant and no medical complications were reported. The surgery was completed using the implant. The event caused a 10 minute delay to the procedure. It is reported the patient is doing well, however the surgeon is unhappy with the asymmetry.
Patient Sequence No: 1, Text Type: D, B5
[113783294]
The design vendor conducted an investigation into the complaint for fit. They concluded, "the most likely underlying cause is unknown. " the implant dimensional analysis scan performed on the first choice (fc) and back up (bu) implants as part of the finished part inspection process were reviewed. The scans determined that both the fc and bu implants were manufactured according to design requirements provided by the customer and met all acceptance requirements. The complaint states that while inserting a screw the implant broke. The complaint cannot be verified as there was no return. There are no indications of manufacturing defects. The most likely cause for the fracture complaint is due to excessive force during plating. The instructions for use (ifu) state,? Using a powered instrument, an appropriately sized pilot hole must be placed at least 4 mm from the perimeter of the implant before inserting any screw. Irrigation while drilling is recommended.? The ifu also states,? They are not intended or designed for full or partial load bearing.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2017-00547 |
| MDR Report Key | 6706752 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-07-12 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2017-10-25 |
| Device Manufacturer Date | 2017-05-10 |
| Date Added to Maude | 2017-07-12 |
| 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 | HARD TISSUE REPLACEMENT-PATIENT MATCHED LEFT FRONTAL SPHENOID PARIETAL TEMPORAL |
| Generic Name | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT |
| Product Code | KKY |
| Date Received | 2017-07-12 |
| Model Number | N/A |
| Catalog Number | PM619381 |
| Lot Number | 755050 |
| 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. Required No Informationntervention | 2017-07-12 |