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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STERILE TRAC SYSTEM THREE LONG DOG BONE SET PLATE, FIXATION, BONE

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ZIMMER BIOMET, INC. STERILE TRAC SYSTEM THREE LONG DOG BONE SET PLATE, FIXATION, BONE Back to Search Results
Catalog Number 15-7378X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Report source: foreign: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up report will be submitted.

 
Event Description

It was reported that the patient had a severe reaction after the initial procedure. No revision procedure has been reported at this time.

 
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Brand NameSTERILE TRAC SYSTEM THREE LONG DOG BONE SET
Type of DevicePLATE, FIXATION, BONE
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 Key10400834
MDR Text Key202687726
Report Number0001825034-2020-03157
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK972322
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number15-7378X
Device LOT Number166410
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/06/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 08/13/2020 Patient Sequence Number: 1
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