MAUDE Adverse Event Report: BIOMET MICROFIXATION HARD TISSUE REPLACEMENT-PATIENT MATCHED BI-FRONTAL IMPLANT; HARD TISSUE REPLACEMENT PATIENT MATCHED IMPLANT

Model Number N/A

Device Problems Crack (1135); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The product was implanted into the patient and therefore will not be returned for an evaluation.Without a product return, no product evaluation is able to be conducted.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.

Event Description

It is reported that a non pre-plated polymethylmethacrylate (pmma) implant was not only sitting very proud, but it didn't fit at all.It is reported the surgeon had to "excessively" burr the implant to make it fit.As a result, the implant cracked in two places when the surgeon proceeded to plate it.It is reported the cracks are near the edges where the surgeon used burr hole plates to secure the corners.It is reported the event resulted in a fifteen minute delay to the procedure.It is reported that there is no revision scheduled for this patient and no injury occurred during the procedure.

Manufacturer Narrative

The product identity was confirmed in the complaint investigation.The implant dimensional analysis scan performed on the first choice (fc) and backup (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 design vendor conducted an investigation into the design of this case.They stated that, ¿the surgeon approved the design of the implant on 12/22/2016 prior to the surgery date of (b)(6) 2017.The surgeon requested a standard fit of 4-8 mm, based on the patient¿s anatomy with a slightly blunt edge resulting in a designed implant thickness of 6 mm.The patient¿s anatomy shows that the frontal area has a thickness range between 5.0 mm and 9 mm, which aligns with the standard fit type.There are a few plates around the defect area that are holding the piece of bone in place above the patients right orbit, but these plates do not cause any scatter that affects the defect at all.However the scan is at 1.985 mm slice spacing with a slice thickness of 2 mm.The most likely underlying cause could possibly be with these increments there could be small bone spurs that do not interpolate from slice to slice causing an improper fit.The cracking of the actual implant could possibly be due to the pre-plating procedure.¿ the complaint cannot be verified as limited details were given and there was no return or pictures of the event.The most likely cause for the fit complaint is surgeon preference and the most likely cause for the hairline fracture complaint is due to excessive force during plating.There are no indications of manufacturing defects.

• Brand Name: HARD TISSUE REPLACEMENT-PATIENT MATCHED BI-FRONTAL IMPLANT
• Type of Device: HARD TISSUE REPLACEMENT PATIENT MATCHED IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6297295
• MDR Text Key: 66446713
• Report Number: 0001032347-2017-00076
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2019
• Device Model Number: N/A
• Device Catalogue Number: PM618890
• Device Lot Number: 728520
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1