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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH 2.3 M VARIAX HAND LOCK 3-D PLATTE,4X2HOLES PLATE, FIXATION, BONE

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STRYKER GMBH 2.3 M VARIAX HAND LOCK 3-D PLATTE,4X2HOLES PLATE, FIXATION, BONE Back to Search Results
Model Number 57-15392
Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 02/25/2022
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
As reported: "a variax hand plate was implanted 6 weeks ago. Skin irritation/inflammation occurred in the area of the plate. After treatment with cortisone failed, the surgeon removed the implants. ".
 
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Brand Name2.3 M VARIAX HAND LOCK 3-D PLATTE,4X2HOLES
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
postfach
freiburg D-791 11
GM D-79111
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13857964
MDR Text Key287660265
Report Number0008031020-2022-00124
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613154496761
UDI-Public07613154496761
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K062498
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number57-15392
Device Catalogue Number57-15392
Device Lot Number1000442418
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/23/2022 Patient Sequence Number: 1
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