MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI 1500889 RT FRT; CUSTOM MADE DEVICE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).G2: foreign - germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a revision occurred due to an unknown reason.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that the patient received a cranial implant approximately two and a half years ago.Subsequently, the patient underwent a revision approximately one year ago due to an epidural infection.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
After receiving additional information and final investigation review, this event was found to be not reportable as this event was found to be unrelated to the implanted zimmer biomet device.The initial report should be voided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.E1: the surgeons associated with this event are l.Tanrikulu and a.Benescu.The following sections were updated: a1; b4; b5; e1; g3; g6; h1; h2; h3; h6; h10 upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HTR-PMI 1500889 RT FRT
• Common Device Name: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17867397
• Report Number: 0001032347-2023-00367
• Device Sequence Number: 14940840
• Product Code: KKY
• UDI-Device Identifier: 00888233035583
• UDI-Public: (01)00888233035583(17)240302(10)029030
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/29/2024

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: 03/02/2024
• Device Model Number: N/A
• Device Catalogue Number: PM623881-A
• Device Lot Number: 029030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/06/2023; 02/26/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/03/2023; 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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; Hospitalization
• Patient Sex: Unknown