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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRX HUM HI PLT LT 11H 197MM PLATE, FIXATION

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ZIMMER BIOMET, INC. PRX HUM HI PLT LT 11H 197MM PLATE, FIXATION Back to Search Results
Catalog Number 110030303
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 10/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Udi: (b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09939. 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. Product not returned.
 
Event Description
It was reported that the incorrect product was found in the package. There was no patient involvement.
 
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Brand NamePRX HUM HI PLT LT 11H 197MM
Type of DevicePLATE, 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 Key8014390
MDR Text Key125305715
Report Number0001825034-2018-09938
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K143697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number110030303
Device Lot NumberRM667K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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