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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 / L14MM PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM PLATE, FIXATION, BONE Back to Search Results
Model Number 657314S
Device Problems Positioning Failure (1158); Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device was discarded.
 
Event Description
As reported: "during the operation, the locking screw did not lock at all. The product was exchanged with the same new one. The procedure completed without problem. ".
 
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Brand NameLOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9924844
MDR Text Key193430302
Report Number0008031020-2020-01053
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K132502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number657314S
Device Catalogue Number657314S
Device Lot NumberD59376
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2020
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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