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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X32MM LOW PRO CORT SCR STE PLATE, FIXATION

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ZIMMER BIOMET, INC. 3.5X32MM LOW PRO CORT SCR STE PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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.
 
Event Description
It is reported that during incoming product inspection the package was found with debris in the sterile area.
 
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Brand Name3.5X32MM LOW PRO CORT SCR STE
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 Key8164242
MDR Text Key130337181
Report Number0001825034-2018-10972
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number851235032
Device Lot Number005190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/31/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2018
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

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