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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN STERNALOCK BLU DEVICE UNKNOWN STERNAL DEVICE

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BIOMET MICROFIXATION UNKNOWN STERNALOCK BLU DEVICE UNKNOWN STERNAL DEVICE Back to Search Results
Model Number N/A
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Reaction (2414)
Event Type  Injury  
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. Occupation¿ patient.

 
Event Description

It was reported by the patient that a sternal closure device may be associated with an allergic reaction. Attempts have been made but no additional information was provided.

 
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Brand NameUNKNOWN STERNALOCK BLU DEVICE
Type of DeviceUNKNOWN STERNAL 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 delaney
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key10356128
MDR Text Key201505885
Report Number0001032347-2020-00330
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNK STERNALOCK BLU
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/22/2020
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 Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/03/2020 Patient Sequence Number: 1
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