MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI BUCKLEY RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT; CUSTOM MADE DEVICE

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.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 the patient had a protrusion in the frontal cranial area following implantation of a custom cranial implant.It is planned that the custom cranial implant will be removed and replaced with a newly designed custom cranial implant.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional and corrected information.It was initially reported that a revision would take place to remove and replace the existing implant, but at this time the device remains implanted and no revision is planned.

• Brand Name: HTR-PMI BUCKLEY RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
• Common Device Name: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9689596
• Report Number: 0001032347-2020-00098
• Device Sequence Number: 1877072
• Product Code: FWP
• UDI-Device Identifier: 00841036251161
• UDI-Public: 00841036251161
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 06/18/2021
• Device Model Number: N/A
• Device Catalogue Number: PM620870
• Device Lot Number: 838560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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
• Patient Age: 34 YR