• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK DVR PLATE ORTHOPAEDIC FIXATION PLATE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. UNK DVR PLATE ORTHOPAEDIC FIXATION PLATE Back to Search Results
Catalog Number UNK DVR PLATE
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 01/27/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that on an unknown date, the unknown dvr plate was removed for an unknown reason. The patient has undergone a revision procedure. Attempts have been made and no additional information has been provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK DVR PLATE
Type of DeviceORTHOPAEDIC FIXATION PLATE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13653925
MDR Text Key286497796
Report Number0001825034-2022-00444
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK DVR PLATE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2022
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: 03/02/2022 Patient Sequence Number: 1
-
-