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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 42MM EXTREMITIES, IMPLANT

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ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 42MM EXTREMITIES, IMPLANT Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 07/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product(s): item# 814510105; hfn lag screw 10. 5mm x 105mm; lot# vf1112305d; item# 814311180; hfn 125 deg 11mm x 180mm; lot# 968030; item# 281001100; ball nose guide wire 100cm; lot# 203690. Report source: foreign: event occurred in (b)(6). 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04272, 0001825034-2019-04273. Remains implanted.
 
Event Description
It was reported that the certificate with the material composition was requested post surgery due to possible intolerance. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameCORTICAL BONE SCR 5.0MM X 42MM
Type of DeviceEXTREMITIES, IMPLANT
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 Key9135358
MDR Text Key162374322
Report Number0001825034-2019-04268
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K100238
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 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number814550042
Device Lot NumberDPNBMY
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 Received02/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/07/2013
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: 09/30/2019 Patient Sequence Number: 1
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