Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / LEFT; PLATE, FIXATION, BONE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / LEFT; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 628008
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/18/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device is not available.
 
Event or Problem Description
The reason for the revision is unknown however the plate and all seven screws were removed from the patient.The patient and her family demanded to have the implants therefore are not available for investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / LEFT
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8259048
Report Number0008031020-2019-00041
Device Sequence Number13761553
Product Code HRS
UDI-Device Identifier07613252441885
UDI-Public07613252441885
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K113760
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/17/2019
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
Operator of Device Lay User/Patient
Device Catalogue Number628008
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/18/2018
Initial Report FDA Received Date01/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-