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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA DVR ANATOMIC NARROW SHORT WITH F.A.S.T. GUIDE INSERTS PLATE, FIXATION

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BIOMET TRAUMA DVR ANATOMIC NARROW SHORT WITH F.A.S.T. GUIDE INSERTS PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problem Bent (1059)
Patient Problem Bone Fracture(s) (1870)
Event Date 04/26/2017
Event Type  Injury  
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to not be reportable. A revision has been indicated due to patient falling causing the fracture (per the surgeon) and is not related to a product issue.
 
Manufacturer Narrative
(b)(4). Unique identifier - (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent a distal radius fracture plating procedure and was revised approximately 3 months post-implantation due to a patient bone fracture. Upon explantation, it was noted that the fracture plate was deformed. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameDVR ANATOMIC NARROW SHORT WITH F.A.S.T. GUIDE INSERTS
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
BIOMET TRAUMA
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 Key6591584
MDR Text Key106911092
Report Number0001825034-2017-03401
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number131212010
Device Lot Number714170
Other Device ID NumberSEE NARRATIVE IN H10
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 Received06/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2016
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: 05/25/2017 Patient Sequence Number: 1
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