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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 / L18MM PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM PLATE, FIXATION, BONE Back to Search Results
Model Number 657318S
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported, the locking screw did not lock when the locking screw was inserted into the plate. I checked the insertion angle and the depth of the drill, and reinserted it several times, but did not lock. I changed it to a screw of the same size and locked it when i put it back in. Doctor's view: "is the screw defective, the plate defective, or the screw too tight?" (b)(4) comment, "it is possible that the screw has contacted hard bone and changed the angle. ".
 
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Brand NameLOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9936221
MDR Text Key193430871
Report Number0008031020-2020-01156
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number657318S
Device Catalogue Number657318S
Device Lot NumberD34233
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2019
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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