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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH WRIST FUSION PLATE STRAIGHT VARIAX 2 WRIST FUSION 120MM PLATE, FIXATION, BONE

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STRYKER GMBH WRIST FUSION PLATE STRAIGHT VARIAX 2 WRIST FUSION 120MM PLATE, FIXATION, BONE Back to Search Results
Model Number 629590
Device Problems Break (1069); Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 06/08/2022
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that a variax 2 wrist plate was revised due to the plate being broken.
 
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Brand NameWRIST FUSION PLATE STRAIGHT VARIAX 2 WRIST FUSION 120MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14852320
MDR Text Key294920239
Report Number0008031020-2022-00296
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327131536
UDI-Public07613327131536
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number629590
Device Catalogue Number629590
Device Lot NumberL07620
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2017
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: 06/29/2022 Patient Sequence Number: 1
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