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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Depression (2361); No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2020

Event Type  Injury  

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 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event 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.

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 Description

No further event information available at the time of this report.

• Type of Device: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10341401
• MDR Text Key: 202780711
• Report Number: 0001032347-2020-00332
• Device Sequence Number: 1
• Product Code: KKY
• UDI-Device Identifier: 00888233026246
• UDI-Public: 00888233026246
• Combination Product (y/n): N
• PMA/PMN Number: K924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention