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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM PLATE, FIXATION, BONE Back to Search Results
Model Number 657312S
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
 
Event Description
It was reported what while inserting the screw, something like an iron powder substance was found. No adverse consequences to the patient were reported.
 
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Brand NameLOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
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
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12269733
MDR Text Key264827260
Report Number0008031020-2021-00329
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K132502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number657312S
Device Catalogue Number657312S
Device Lot NumberH31710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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