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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN DVR PLATE PROSTHESIS, WRIST

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BIOMET ORTHOPEDICS UNKNOWN DVR PLATE PROSTHESIS, WRIST Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 07/25/2014
Event Type  Injury  
Manufacturer Narrative
(b)(6). Therapy date: (b)(6) 2014. Report source, literature - luigi tarallo, raffaele mugnai, roberto adani & fabio catani (2014) malunited extra-articular distal radius fractures: corrective osteotomies using volar locking plate. J orthopaed traumatol (2014) 15:285-290. Https://rd. Springer. Com/content/pdf/10. 1007%2fs10195-014-0307-x. Pdf reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. -.
 
Event Description
It was reported there were two cases of transient median neuroapraxia that resolved before the 6-week follow-up appointment. Patients had previously undergone corrective osteotomy using a volar locking plate.
 
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Brand NameUNKNOWN DVR PLATE
Type of DevicePROSTHESIS, WRIST
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6794539
MDR Text Key82695487
Report Number0001825034-2017-06361
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
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 Received07/18/2017
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 Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/15/2017 Patient Sequence Number: 1
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