• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK 360 MULTI-IMPLANT SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET MICROFIXATION STERNALOCK 360 MULTI-IMPLANT SYSTEM Back to Search Results
Model Number N/A
Device Problems Device Inoperable (1663); Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 11/02/2016
Event Type  Injury  
Manufacturer Narrative
Review of the device history records show that the lot was released with no recorded anomaly or deviation. The possible adverse effects in the package insert state this type of event can occur. The product was discarded by the hospital and therefore will not be returned for an evaluation. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
 
Event Description
It was reported that one of the devices completely broke off the sternal band while tensioning which required them to open another kit in order to get a single device out to complete the procedure. It is reported that the band did not break in to pieces but that it came free from the tower while the surgeon was tightening to fixate it. It is reported that no delay over thirty minutes occurred as a result of this event. It is reported that no injury to the patient occurred as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTERNALOCK 360 MULTI-IMPLANT SYSTEM
Type of DeviceMULTI-IMPLANT SYSTEM
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 Key6129907
MDR Text Key60962985
Report Number0001032347-2016-00690
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK151019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/16/2018
Device Model NumberN/A
Device Catalogue Number74-0004
Device Lot Number261460
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/28/2016 Patient Sequence Number: 1
-
-