MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM; SCRW 2.4X14MM CANCELOUS LOCKNG

Model Number N/A

Device Problems Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Distributor reported a revision surgery due to the screws backing out of the plate.The distributor stated the parts were discarded; therefore, there is no return for this file.The distributor reported that the surgeon indicated the patient had good bone quality, but was non-compliant with post-operative instructions and was "very active with his upper body very soon after surgery".

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.File 4 of 4.

• Brand Name: STERNALOCK BLU BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
• Type of Device: SCRW 2.4X14MM CANCELOUS LOCKNG
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle coldwater ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 4149406
• MDR Text Key: 4765121
• Report Number: 0001032347-2014-00361
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2414
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR