MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR*PMI 2025734 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT; CUSTOM MADE DEVICE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Necrosis (1971); Fluid Discharge (2686)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00405, 0001032347-2020-00406.Concomitant medical products: htr*pmi 2025734 left frontal temporal parietal implant, part# pm623210-b, lot# 986060.1.5mm system 6 hole extra long double y plate, part# 01-7114, lot# j416200.1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# j416220.Unknown screws, part# ni, lot# ni.Telephone number: (b)(6).The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported a custom cranioplasty plate was removed due to necrosis two (2) months after implantation.A few days after surgery, a bruise was observed in the skin over the middle of the implant, and the bruise did not improve.Two (2) weeks prior to removal, the spot on the skin opened up with fluid escaping.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00404, 0001032347-2020-00405, 0001032347-2020-00406, 0001032347-2020-00430, 0001032347-2020-00431.D11 ¿ medical products htr*pmi 2025734 left frontal temporal parietal implant, part# pm623210-b, lot# 986060 1.5mm system 6 hole extra long double y plate, part# 01-7114, lot# j416200 1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# j416220 1.5mm system high torque (ht),sd,x-dr,screw 1.5mm x 5mm, part# 91-6105, lot# ni 1.5mm system high torque (ht) cross-drive screw 1.8 x 5mm, part# 91-1805, lot# ni the following fields were updated: b4 date of this report b5 describe event or problem d11 medical product g4 date received by manufacturer g7 type of report h2 follow up type h10 additional narratives/data.
Event or Problem Description
It was reported a custom cranioplasty plate was removed due to necrosis two (2) months after implantation.A few days after surgery, a bruise was observed in the skin over the middle of the implant, and the bruise did not improve.Two (2) weeks prior to removal, the spot on the skin opened up with fluid escaping.It has not been determined if the back-up implant will be used or if a new custom plate will be implanted in the coming months.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The investigation conducted by the designer and manufacturer for item# pm623210-b found no deviations, non-conformities, or anomalies related to the complaint.The issue was concluded to not be related to the design or manufacture of the device.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: 10475092
• Report Number: 0001032347-2020-00404
• Device Sequence Number: 17199666
• Product Code: KKY
• UDI-Device Identifier: 00888233026000
• UDI-Public: 00888233026000
• 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
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: N/A
• Device Catalogue Number: PM623210-B
• Device Lot Number: 986060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 09/04/2020; 03/26/2021
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/09/2020; 03/31/2021
• 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: Hospitalization; Required Intervention