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 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 Problems Failure to Align (2522); Migration (4003)
Patient Problems Pain (1994); Injury (2348); Disability (2371)
Event Date 09/02/2016
Event Type  Injury  
Event Description
It was reported that the right side screw is not lined up with left side and it is poking through anterior sacrum almost 3 threads.The patient allegedly become disabled with entire body pain and spinal pain throughout.
 
Manufacturer Narrative
Method: nc/capa history review, labelling review, risk assessment.Result: the customer reported event was not confirmed as the hospital refused to provide any additional information about this event.The hospital would not provide any additional information after several attempts.The lot number was not provided, so a manufacturing record review could not be performed.Conclusion: a root cause could not be determined as not enough information was provided to perform an investigation.Possible root causes include preparing the screw hole too deep, incorrect screw size, incorrect trajectory, poor bone quality, excessive post op activity, and/or patient fall.Device not returned.
 
Event Description
It was reported that the right side screw is not lined up with left side and it is poking through anterior sacrum almost 3 threads.The patient allegedly become disabled with entire body pain and spinal pain throughout.
 
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
MDR Report Key8081374
MDR Text Key127532314
Report Number0009617544-2018-00269
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K060361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
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
Date Manufacturer Received01/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age39 YR
Patient Weight51
-
-