MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM 6 HOLE EXTRA LONG DOUBLE Y PLATE; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/09/2020
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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00276, 0001032347-2020-00278.Medical products: htr pmi burger right temporal parietal implant, part# pm622515, lot# 937140.1.5mm system 6 hole extra long double y plate, part# 01-7114, lot# ni.1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# ni.
Event or Problem Description
It was reported a custom cranial implant was removed due to infection.The surgeon does not believe the implant was the cause of the infection.No additional patient consequences have been reported.
Additional Manufacturer Narrative
The following fields were updated: b4 date of this report b5 describe event or problem 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 cranial implant was removed due to infection.The surgeon does not believe the implant was the cause of the infection.A new custom implant was implanted and the patient is currently on antibiotics.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed, because a revision surgery was reported.The devices were not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no functional testing or visual evaluations could be conducted.The dhr could not be reviewed due to the lot numbers remaining unknown.There are no indications of manufacturing defects.The most likely underlying cause could not be determined from the information provided.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
This follow-up report is being submitted to relay additional information.

• Brand Name: 1.5MM SYSTEM 6 HOLE EXTRA LONG DOUBLE Y PLATE
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10180073
• Report Number: 0001032347-2020-00277
• Device Sequence Number: 16829588
• Product Code: JEY
• UDI-Device Identifier: 00841036013004
• UDI-Public: 00841036013004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-7114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/23/2020; 12/22/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/24/2020; 12/28/2020
• 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