• 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 10 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 10 HOLE / LEFT PLATE, FIXATION, BONE Back to Search Results
Catalog Number 628010
Device Problems Bent (1059); Fracture (1260)
Patient Problem No Information (3190)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It is reported that on 8 feb, a patient received a variax clavicle plate, with a mid-shaft fracture. On (b)(6) on the control picture the plate seems to be bent. On (b)(6) the patient reports that there is a lumb and pain. The plate appears broken. On (b)(6) a recovery operation was done with an acumed plate (is thicker according to the doctor). The plate was intact at insertion. Is also not bent during ok and screws are placed according to procedure.
 
Manufacturer Narrative
The reported event that superior plate - decreased curvature variax clavicle 10 hole/left was alleged of 'implant breakage after surgery' could be confirmed. Based on investigation, the root cause was attributed to be patient related. The failure was caused by an overloading/precocious weightbearing on the implant. Indeed, the device inspection revealed the following: the clavicle plate is indeed broken in two pieces, at the level of the third circular hole on the medial side. The microscope inspection of the breakage surface show a shiny area, which proves that the two parts of the broken plate rubbed against each other for a while before the plate snapped completely (grey area corresponding to sudden fracture). Furthermore, on the shiny area, "beach marks" features can be noticed clearly. This behavior is usually caracteristic to fatigue fractures. As a reminder, the ifu clearly states: "post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time. For this reason post-operative instructions and warnings to patients are extremely important. External immobilization (e. G. Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation. " a review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation. If any further information is provided, the investigation report will be updated.
 
Event Description
It is reported that on (b)(6), a patient received a variax clavicle plate, with a mid-shaft fracture. On (b)(6) on the control picture the plate seems to be bent. On (b)(6) the patient reports that there is a lumb and pain. The plate appears broken. On (b)(6) a recovery operation was done with an acumed plate (is thicker according to the doctor) the plate was intact at insertion. Is also not bent during ok and screws are placed according to procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 10 HOLE / LEFT
Type of DevicePLATE, FIXATION, BONE
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 Key7433420
MDR Text Key105573099
Report Number0008031020-2018-00297
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K113760
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number628010
Device Lot NumberL23482
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/03/2017
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: 04/16/2018 Patient Sequence Number: 1
-
-