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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN DISTAL LOCKING SCREW IMPLANT

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STRYKER GMBH UNKNOWN DISTAL LOCKING SCREW IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problems Loose or Intermittent Connection (1371); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device evaluated by mfr: device disposition unknown.
 
Event Description
The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6) medical center. The title of this report is ¿a post market clinical follow-up (pmcf) of the treatment of elbow fractures with the stryker variax elbow plate system¿ which was published in april 2019 and is associated with stryker variax elbow plate system. Within that publication, post-operative complications/ adverse events were reported, which occurred between 2012 and 2018. It was not possible to ascertain specific device or patient information from the article; 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, 8 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses hardware irritation. 1 out of 2 cases. The study states, ¿the first and the second patient developed hardware irritation. The first patient had their distal locking screws lose purchase in the plate and back out. [¿] no hardware had to be removed. [¿] both patients went on to consolidation. ¿.
 
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Brand NameUNKNOWN DISTAL LOCKING SCREW
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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8703667
MDR Text Key148161865
Report Number0008031020-2019-00559
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2019
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 Received05/22/2019
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: 06/17/2019 Patient Sequence Number: 1
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