MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR*PMI KURIC BI-FRONTAL PARIETAL IMPLANT; CUSTOM MADE DEVICE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 cranioplasty plate fractured due to a sports injury approximately five (5) years following implantation.Inquires have been made regarding a replacement implant but no revision surgery is scheduled at this time.No additional patient consequences have been reported.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The device fractured due to external trauma, not caused by the device.There is no alleged device deficiency, and the device served it's intended purpose.The patient sustained trauma that this device would not be expected to withstand during normal use.The initial report was forwarded in error and should be voided.
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: 10451268
• Report Number: 0001032347-2020-00387
• Device Sequence Number: 11676528
• Product Code: KKY
• UDI-Device Identifier: 00841036202873
• UDI-Public: 00841036202873
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K924935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 07/16/2021

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: 11/20/2018
• Device Model Number: N/A
• Device Catalogue Number: PM617367
• Device Lot Number: 649840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2020
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 07/16/2021
• 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