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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX INC. VOLAR DISTAL RAD PLT TI STD LT 3H PLATE, FIXATION, BONE

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ARTHREX INC. VOLAR DISTAL RAD PLT TI STD LT 3H PLATE, FIXATION, BONE Back to Search Results
Catalog Number AR-8916VSL-03
Device Problems Bent (1059); Crack (1135); Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 02/12/2018
Event Type  Injury  
Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. Device history record review revealed nothing relevant to this event. The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified. The cause of the event could not be determined from the information available and without device evaluation. The potential causes of this event are being communicated to the event reporter. If the device is returned and additional information is obtained, a follow-up report will be submitted.
 
Event Description
It was reported that the original procedure was performed (b)(6) 2018. Case: distal radius. Everything went well with the original surgery to the best of the surgeon's knowledge. On (b)(6) 2018, patient had a revision because the plate cracked or bent and the one of more screws were backing out. Surgeon was going to go back in and tighten them down, however, upon screwing them back in; the screws were not holding. The surgeon ended up having to replace the right sided plate and four screws. Follow up information: after a patient fall 4 of the distal screws backed out of the plate resulting in surgeon need to perform a revision on (b)(6) 2018.
 
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Brand NameVOLAR DISTAL RAD PLT TI STD LT 3H
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath, adverse events
1370 creekside boulevard
naples, FL 34108-1945
8009337013
MDR Report Key7321369
MDR Text Key101838306
Report Number1220246-2018-00077
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAR-8916VSL-03
Device Lot Number10159177
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
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: 03/07/2018 Patient Sequence Number: 1
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