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 LATERAL PLATE VARIAX CLAVICLE 7 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 LATERAL PLATE VARIAX CLAVICLE 7 HOLE / LEFT; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 628207
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/05/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.
 
Event or Problem Description
Use 7 hole plate.Did not use the aiming block.Finally, drilled almost vertically against the re-distal anterior screw hole, but the screw did not lock.Drilling by bicortically but did not lock.Could not lock it even with a new screw and ended the operation without locking.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / LEFT
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key7923895
Report Number0008031020-2018-00686
Device Sequence Number1722268
Product Code HRS
UDI-Device Identifier07613252442325
UDI-Public07613252442325
Combination Product (Y/N)N
PMA/510(K) Number
K113760
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number628207
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/06/2018
Initial Report FDA Received Date10/01/2018
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 Other;
Patient Age56 YR
-
-