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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX ELBOW LATERAL COLUMN PLATE IMPLANT

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STRYKER GMBH UNKNOWN VARIAX ELBOW LATERAL COLUMN PLATE IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 01/01/2011
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible. Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided. If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a post-market clinical follow-up (pmcf) from (b)(6). The title of this report is ¿a retrospective data collection treatment of elbow fractures with the variax elbow plating system¿ which is associated with the 'stryker variax elbow locking plating system'. Within that publication, post-operative complications/ adverse events were reported which occurred between january 2011 to december 2018. It was not possible to ascertain specific device or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 9 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses wound drainage and irrigation and debridement and removal of the lateral column plate. The pmcf states, ¿one patient suffered a wound complication resulting in exposed hardware requiring multiple irrigation and debridements and eventual removal of hardware. Of note, the patient suffers from dementia. [¿] the patient subsequently developed wound drainage and was taken back for irrigation and debridement and removal of the lateral column plate two months after the previous irrigation and debridement and removal of medial column plate. The patient went on to have an uneventful recovery and was able to achieve both clinical and bony consolidation approximately four months after the index procedure. ¿.
 
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Brand NameUNKNOWN VARIAX ELBOW LATERAL COLUMN PLATE
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8910733
MDR Text Key156408394
Report Number0008031020-2019-01070
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
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 Received07/26/2019
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: 08/20/2019 Patient Sequence Number: 1
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