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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK PLATE, BONE

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BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK PLATE, BONE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Necrosis (1971); Fluid Discharge (2686)
Event Date 08/26/2020
Event Type  Injury  
Manufacturer Narrative

Zimmer biomet complaint (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. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00404, 0001032347-2020-00405. Medical products: htr*pmi 2025734 left frontal temporal parietal implant, part# pm623210-b, lot# 986060. 1. 5mm system 6 hole extra long double y plate, part# 01-7114, lot# j416200. 1. 5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# j416220. Unknown screws, part# ni, lot# ni. (b)(6). The user facility is foreign; therefore, a facility medwatch report will not be available. Foreign report source: (b)(6).

 
Event Description

It was reported a custom cranioplasty plate was removed due to necrosis two (2) months after implantation. A few days after surgery, a bruise was observed in the skin over the middle of the implant, and the bruise did not improve. Two (2) weeks prior to removal, the spot on the skin opened up with fluid escaping. No additional patient consequences have been reported.

 
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Brand Name1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK
Type of DevicePLATE, BONE
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 delaney
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key10475095
MDR Text Key205093888
Report Number0001032347-2020-00406
Device Sequence Number1
Product Code JEY
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK121589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number91-6104
Device LOT NumberJ416220
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/04/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/20/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/31/2020 Patient Sequence Number: 1
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