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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.
 
Manufacturer Narrative
Report source foreign - (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
PRX HUM HI PLT LT 11H 197MM
Type of Device
PLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8014390
MDR Text Key125305715
Report Number0001825034-2018-09938
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K143697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Catalogue Number110030303
Device Lot NumberRM667K
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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