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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH DR IMPLANT KIT, NARROW SHORT LEFT VARIAX2 XPRESS 56MM PLATE, FIXATION, BONE

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STRYKER GMBH DR IMPLANT KIT, NARROW SHORT LEFT VARIAX2 XPRESS 56MM PLATE, FIXATION, BONE Back to Search Results
Model Number 991053S
Device Problems Positioning Failure (1158); Material Fragmentation (1261); Difficult to Insert (1316)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
The surgeon was using a variax2 dr implant kit together with an ordinary instrument kit. When inserting a locking screw, he experienced that the screw would not engage in the plate and some metal chips were detected. They kept the plate in place and used other screws in the plate.
 
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Brand NameDR IMPLANT KIT, NARROW SHORT LEFT VARIAX2 XPRESS 56MM
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 Key9747382
MDR Text Key193407937
Report Number0008031020-2020-00512
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K162841
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 04/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number991053S
Device Catalogue Number991053S
Device Lot NumberL34324
Was Device Available for Evaluation? No
Date Returned to Manufacturer02/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2017
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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