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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN PECTUS SUPPORT BAR UNKNOWN PECTUS BAR

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BIOMET MICROFIXATION UNKNOWN PECTUS SUPPORT BAR UNKNOWN PECTUS BAR Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Event Date 11/17/2020
Event Type  Injury  
Manufacturer Narrative

Zimmer biomet complaint (b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

 
Event Description

It was reported the patient underwent a revision of two (2) pectus support bars due to undiagnosed metal allergy. The bars were replaced with titanium pectus support bars. Attempts have been made and no further information has been provided.

 
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Brand NameUNKNOWN PECTUS SUPPORT BAR
Type of DeviceUNKNOWN PECTUS BAR
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 Key10934729
MDR Text Key219158695
Report Number0001032347-2020-00594
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061384
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN PECTUS BAR
Device LOT NumberUNKNOWN
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 Received03/18/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 12/02/2020 Patient Sequence Number: 1
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