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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX LOCKING PLATE; IMPLANT

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STRYKER GMBH UNKNOWN VARIAX LOCKING PLATE; IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 03/01/2012
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition unknown.
 
Event Description
The manufacturer became aware of a study from department of orthopedic surgery, bürgerspital solothurn.The title of this study is ¿the first 100 patients treated with a new anatomical pre-contoured locking plate for clavicular midshaft fractures¿ and is associated with the variax clavicle locking plate system.Within that publication, post-operative complications/ adverse events were reported, which occurred between march 2012 and january 2016.It was not possible to ascertain specific device catalogs 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 46 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses failed osteosynthesis because of surgical implantation fault.1 out of 2 cases.The study states, ¿failures occurred due to surgical errors where the medial screws were not placed bi-cortically, with subsequent medial plate loosening¿.
 
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Brand Name
UNKNOWN VARIAX LOCKING PLATE
Type of Device
IMPLANT
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 Key8368328
MDR Text Key137117612
Report Number0008031020-2019-00126
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/03/2019
Initial Date FDA Received02/25/2019
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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