MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR * PMI M.Y.1990 LEFT FRONTAL PARIETAL TEMPORAL IMPLANT; CUSTOM MADE DEVICE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint cmp (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.Medical products 1.5mm system 2 hole long straight plate, part# 01-7347, lot# ni 1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# ni (b)(6).

Event Description

It was reported the patient underwent a revision of a custom cranioplasty plate four (4) months following implantation due to patient dissatisfaction with the cosmetic result.The device was removed and replaced with an unspecified implant.It was reported that no further information is available.

Manufacturer Narrative

No further event information available at the time of this report.This follow-up report is being submitted to relay additional information.Conflicting information was initially received regarding the product identity.This report is being submitted to provide the updated product identity.A2 ¿ patient¿s birth year is 1990.This report is being submitted to update section h2, h10 and correction to a1, a2, d1, d4, h4.

Event Description

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

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 related to the reported event.A definitive root cause cannot be determined.The investigation from the manufacturer noted that there were no design/manufacturing process issues that would have contributed to this complaint.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: 11261678
• MDR Text Key: 229800234
• Report Number: 0001032347-2021-00037
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• PMA/PMN Number: K924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: N/A
• Device Catalogue Number: PM621597-B
• Device Lot Number: 887570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention