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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCKING ONE-THIRD TUBULAR PLATE 6 HOLES 81 MM LENGTH SCREW, FIXATION

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ZIMMER BIOMET, INC. LOCKING ONE-THIRD TUBULAR PLATE 6 HOLES 81 MM LENGTH SCREW, FIXATION Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available
Event Date 09/04/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4) (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 mdr will be submitted. Remains implanted.

 
Event Description

It was reported that a patient underwent an initial trauma procedure. Subsequently, the patient was implanted with a fracture plate but is experiencing non-healing from the osteotomy. Attempts have been made and additional information on the reported event is unavailable.

 
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Brand NameLOCKING ONE-THIRD TUBULAR PLATE 6 HOLES 81 MM LENGTH
Type of DeviceSCREW, FIXATION
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 Key7428400
Report Number0001822565-2018-02112
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number47493600603
Device LOT Number63369512
OTHER Device ID Number(01) 00889024104099
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 Received05/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/23/2016
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: 04/13/2018 Patient Sequence Number: 1
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