MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR*PMI 106871/E.D.L.66 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT; CUSTOM MADE DEVICE

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Depression (2361); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The user facility is foreign; therefore, a facility medwatch report will not be available.(b)(6).
Event or Problem Description
It was reported the custom cranioplasty plate did not fit as expected upon implantation.The implant did not match the defect and had to be altered with a milling machine.Upon implantation, the implant still protrudes and it was difficult to close the skin.A surgical delay greater than thirty (30) minutes was reported.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported the custom cranioplasty plate did not fit as expected upon implantation.The implant did not match the defect and had to be altered with a milling machine.Upon implantation, the implant still protrudes and it was difficult to close the skin.A surgical delay of one and a half hours was reported.During outpatient follow-up, the doctor noted that the cosmetic aspect is suboptimal and the plate is visible as a slight elevation in the forehead.The suboptimal cosmetic aspect has negatively impacted the patient¿s existing depression.No additional patient consequences were reported.
Additional Manufacturer Narrative
Visual examination of the post-operative scans by the designer/manufacturer, zb cas, identified a 7 mm gap between the defect and the implant around the frontal and top region.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Review of complaint history search for part 'pm' in item class 'htr' identified [10] additional report(s) for a same or similar event from (b)(6) 2019: present.A lot number search is not applicable because this is a custom, patient matched implant with lot quantity one.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Common Device Name: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10341401
• Report Number: 0001032347-2020-00332
• Device Sequence Number: 19047553
• Product Code: KKY
• UDI-Device Identifier: 00888233026246
• UDI-Public: 00888233026246
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K924935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: N/A
• Device Catalogue Number: PM623280
• Device Lot Number: 987270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 10/30/2020; 01/25/2021
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 11/06/2020; 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention