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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 Known Impact Or Consequence To Patient (2692)
Event Date 12/25/2019
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
When inserting the locking screw (657312s) into the plate ((b)(4)), a thin metal piece was generated. It has been removed and no longer remains in the body.
 
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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
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 Key9614115
MDR Text Key193347098
Report Number0008031020-2020-00112
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327086829
UDI-Public07613327086829
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 04/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number657312S
Device Catalogue Number657312S
Device Lot NumberD50232
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2019
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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