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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING, 2.4 X 16MM BONE SCREW

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BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING, 2.4 X 16MM BONE SCREW Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem No Information (3190)
Event Date 08/08/2018
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4). Medical product: biomet microfixation sternalock 360 multi implant system catalog #: 74-0004 lot #: 563510, biomet microfixation sternalock blu system screw, cancellous cross-drive locking 2. 4 x 18mm catalog #: 73-2418 lot #: ni. Foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was discarded. 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: 0001032347-2018-00777-1 and 0001032347-2018-00871.
 
Event Description
It was reported there was a revision due to the bands pulling through the sternum. The patient had a coughing fit about a week after the primary operation and the sternalock 360 bands pulled through the sternum. The surgeon removed the implants and revised the patient with a robicsek wiring technique to hold the sternum together. The surgeon advised that this can happen when such a patient with a high bmi coughs a lot. No additional patient consequences were reported.
 
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Brand NameSTERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING, 2.4 X 16MM
Type of DeviceBONE SCREW
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
michelle cole
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key8170601
MDR Text Key130536231
Report Number0001032347-2018-00870
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K161896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number73-2416
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 Received03/01/2019
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

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
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