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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX SCREW (NO. OF SCREWS USED: 2 TO = 12) IMPLANT

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STRYKER GMBH UNKNOWN VARIAX SCREW (NO. OF SCREWS USED: 2 TO = 12) IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscular Rigidity (1968); Pain (1994); Non-union Bone Fracture (2369)
Event Date 05/06/2020
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from university of kentucky, usa. The title of this report is ¿a retrospective data collection of the treatment of wrist fractures with the variax distal radius locking plate system¿ which is associated with the stryker ¿variax distal radius locking plate system¿ system. The research period of patients included in this report was between 9/2019 and 2/2020. It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints. Therefore, 20 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses prolonged stiffness, pain and delayed radiographic consolidation. The report states: ¿one subject was treated for an extra-articular fracture from a fall from standing. The subject had prolonged stiffness and pain and never reached clinical consolidation. The subject¿s husband was noted to be a heavy smoker, which may have contributed to the delayed radiographic consolidation. ¿.
 
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Brand NameUNKNOWN VARIAX SCREW (NO. OF SCREWS USED: 2 TO = 12)
Type of DeviceIMPLANT
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 Key10150999
MDR Text Key195084273
Report Number0008031020-2020-01642
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
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 Received05/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/12/2020 Patient Sequence Number: 1
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