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 SPINE-US ANCHOR C DIAM 3.5MM SELF DRILLING 8MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
  • 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 SPINE-US ANCHOR C DIAM 3.5MM SELF DRILLING 8MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL Back to Search Results
Catalog Number 6741608
Device Problems No Apparent Adverse Event (3189); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
It was reported that the anchor c self drilling screws at c4/5 migrated approximately 2 months post operatively.Revision surgery has not been preformed or scheduled at this time.This is the second of 2 screws.
 
Manufacturer Narrative
B.5 was updated with the receipt of additional information from the field representative indicates there is no malfunction relating to this device.The event of the migrated anchor c screw is captured under report 3005525032-2021-00029.H3 other text: status and location of the device is unknown.
 
Event Description
It was initially reported that two anchor c self drilling screws at c4/5 migrated approximately 2 months post operatively.However, upon additional information received, only one screw migrated.Revision surgery was performed where the one screw was explanted.This report captures the screw for which there is no allegation of issues.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANCHOR C DIAM 3.5MM SELF DRILLING 8MM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key12046532
MDR Text Key260118082
Report Number3005525032-2021-00028
Device Sequence Number1
Product Code OVE
Combination Product (y/n)N
PMA/PMN Number
K102606
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6741608
Was Device Available for Evaluation? No
Date Manufacturer Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-