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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L50MM PLATE, FIXATION, BONE

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STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L50MM PLATE, FIXATION, BONE Back to Search Results
Model Number 657450S
Device Problem Material Fragmentation (1261)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
The customer reported that during the case the screw thread on 3 screws appears to have stripped off in places.
 
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Brand NameBONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L50MM
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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10485319
MDR Text Key206568176
Report Number0008031020-2020-02205
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327074277
UDI-Public07613327074277
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K132502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number657450S
Device Catalogue Number657450S
Device Lot NumberD41940
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2019
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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