MAUDE Adverse Event Report: BIOMET MICROFIXATION HARD TISSUE REPLACEMENT PATIENT-MATCH IMPLANT (RIGHT FRONTAL PARIETAL TEMPORAL)

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

Review of 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 user facility is foreign; therefore, a facility medwatch report will not be available.The product was implanted into the patient and therefore will not be returned for an 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.(b)(4).Report one (1) of two (2) for the same event.Report 2 of 2 is reported on 0001032347-2016-00174.

Event Description

It was reported that during a bilateral case, two (2) separate implants did not fit well and required significant modification to achieve proper fit.The left side was implanted first and the right side was implanted second.The curvature of the first (left) implant in the temporal area was too concave and a backup implant was used to fill the gaps and bolster the implant up in order to achieve the desired cosmetic result.The second (right) implant was said to be better but still required significant modification to achieve proper fit.The increase in surgical time was thirty-eight (38) minutes for the first (left) implant and less than thirty (30) minutes (exact time is unknown) for the second (right) implant.

Manufacturer Narrative

The products were not returned for evaluation, however the patient's scans, photographs of the procedure, and manufacturing process for the implants were evaluated by the manufacturer.Based on the evaluation, the complaint was confirmed through intraoperative pictures.The most-likely, underlying cause was determined to be the patient's anatomy between the time of the ct scan and the time of the surgery.The ct scan was 285 days old at the time of the surgery.Based on the review of the manufacturing process during the evaluation, the scans determined that the implants were manufactured according to design requirements provided by the customer and met all acceptance requirements.Additionally, "the digital mold, mold of mold, and implant files were all examined and no design flaws were found.The parts were examined to ensure no gaps or overlaps existed between parts that could lead to the caste implant being too large or different from the implant design." also, "scan date was (b)(6) 2015 and the surgery date was (b)(6) 2016.No post op scans were provided for verification.The time between the scan data and surgery may have allowed for bone growth or movement resulting in the improper fit of the implant." this is report 2 of 2 for the same event.Report 1 of 2 is reported on mfr #0001032347-2016-00174-1.

• Brand Name: HARD TISSUE REPLACEMENT PATIENT-MATCH IMPLANT (RIGHT FRONTAL PARIETAL TEMPORAL)
• Type of Device: 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: 5584651
• MDR Text Key: 42895024
• Report Number: 0001032347-2016-00173
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2019
• Device Model Number: N/A
• Device Catalogue Number: PM617644-B
• Device Lot Number: 664590
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization