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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM 2.7X12MM HIGH TORQUE X-DRIVE SCREW

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BIOMET MICROFIXATION LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM 2.7X12MM HIGH TORQUE X-DRIVE SCREW Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device ; Noise, Audible
Event Date 04/25/2017
Event Type  Injury  
Manufacturer Narrative

No x-rays, scans, pictures, or physician's reports were provided. The devices currently remain implanted, therefore no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. The warnings in the package insert state this type of event can occur. 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. This is report four of six for the same event; reference reports 0001032347-2017-00654 through 0001032347-2017-00659.

 
Event Description

The patient reported he has experienced squeaking which is worse in cold weather and popping of the jaw. He followed up with his surgeon who stated a screw is loose; the tmj implants will be removed and replaced in (b)(6).

 
Manufacturer Narrative

The patient advised the loose screw was determined to be due to his bone hollowing out over time. This is supplemental report four of six for the same event, supplemental reports one through six are reported on mfr #0001032347-2017-00654-1 through 0001032347-2017-00659-1.

 
Event Description

The patient provided the following additional information: the revision surgery was scheduled to take place on (b)(6) 2017. In addition, he reports there is bone growth around the implant and some of the gum will need to be removed. The patient advised the loose screw was determined to be due to his bone hollowing out over time. He states new implants will be placed during the revision. At this time no confirmation has been received that the revision occurred.

 
Manufacturer Narrative

This is supplemental report four of six for the same event; reference reports 0001032347-2017-00654-2 through 0001032347-2017-00659-2.

 
Event Description

The surgeon's office confirmed the revision was performed, the prosthesis was fine, the bone growth around the joint was removed, and the squeaking has stopped. Additional information was requested but has not been received at this time.

 
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Brand NameLORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
Type of Device2.7X12MM HIGH TORQUE X-DRIVE 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 Key6791143
Report Number0001032347-2017-00657
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 10/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator DEVICE UNATTENDED
Device MODEL NumberN/A
Device Catalogue Number91-2712
Device LOT NumberUNKNOWN
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
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
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/14/2017 Patient Sequence Number: 1
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