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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 / L22MM PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L22MM PLATE, FIXATION, BONE Back to Search Results
Model Number 657322S
Device Problems Positioning Failure (1158); Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2020
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 could not be completely fastened. The doctor tried to turn it with a screwdriver many times, but i couldn't turn the screw on the way. Doctor's view: the patient's bones were stiff and the screw could not advance. The tip of the screwdriver has come off the screw head many times. It would be nice to have a screw that can be inserted even in patients with hard bones. I want the tip of the screwdriver to be shaped so that it does not come off the screw head. ".

 
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Brand NameLOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L22MM
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11121220
MDR Text Key227976844
Report Number0008031020-2021-00006
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK132502
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 04/09/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/05/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number657322S
Device Catalogue Number657322S
Device LOT NumberY18797
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/16/2018
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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