• 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 UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

  • 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 UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPN
Device Problem Fracture (1260)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 01/06/2016
Event Type  Injury  
Event Description
It was reported that the patient underwent spinal surgery involving a screw which fractured post-operatively.
 
Manufacturer Narrative
Result: the reported device was not able to be identified since no product details were provided.A manufacturing record review, complaint history review or an nc/capa history could not be performed.Risk analysis could not be performed.Conclusion: the root cause of the reported event could not be determined due to lack of information and no product return for evaluation.Plausible causes include but not limited to: excessive patient post-op activities beyond surgeon recommendation.Patient experiences a fall.Patient non-fusion.Poor fixation construct.Device used beyond intended use.Improper screw insertion.Poor bone quality.Device not returned.
 
Event Description
It was reported that the patient underwent spinal surgery involving a screw which fractured post-operatively.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer Contact
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8166839
MDR Text Key130459271
Report Number3004024955-2018-00058
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/31/2019
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? Yes
Device Operator No Information
Device Catalogue NumberUNK_SPN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/19/2018
Initial Date FDA Received12/14/2018
Supplement Dates Manufacturer Received01/25/2019
Supplement Dates FDA Received01/31/2019
Was Device Evaluated by Manufacturer? No
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) Other;
-
-