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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPN
Device Problem Malposition of Device (2616)
Patient Problems Neuropathy (1983); Pain (1994)
Event Date 01/01/2011
Event Type  Injury  
Manufacturer Narrative
Status and location of the device is unknown.
 
Event Description
Through journal article 'dynamic versus rigid stabilization for the treatment of disc degeneration in the lumbar spine' in evidence-based spine-care journal, volume 2: issue 3 (2011), it was reported that a patient required reoperation due to "nerve root irritation and pain" attributed to "pedicle screw misplacement." after revision surgery, all fusions were solid with positive sentinel sign on x-ray at final follow-up.The study aimed to describe the outcome of stabilization surgery with dynamic instrumentation for degenerative disc disease.In total, the success rates of 25 patients treated with stabilization of the involved vertebral dynamic unit(s) with either dynamic or rigid instrumentation with or without additional decompression were analyzed.The dynamic group was implanted with non-stryker devices and the rigid group with stryker devices.The device information is reported as 'xia, stryker spine, allendale, new jersey, usa'; catalog and lot numbers are not provided.
 
Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a catalog or lot number was not provided.This complaint was opened as a result of a study review titled 'dynamic versus rigid stabilization for the treatment of disc degeneration in the lumbar spine'.In total, the success rates of 25 patients treated with stabilization of the involved vertebral dynamic unit(s) with either dynamic or rigid instrumentation with or without additional decompression were analyzed.The dynamic group was implanted with non-stryker devices and the rigid group with stryker devices.The implant information was reported as xia, no catalog and lot number was provided.Per the article, one patient in the rigid group required reoperation because of misplacement of the xia pedicle screw which resulted in nerve root irritation and pain.After the revision surgery with rigid instrumentation, the patient achieved fusion which was verified through an x-ray at final follow-up.Screw misplacement does not indicate device failure but is a result or user error.Xia surgical technique indicates that the surgeon is to be thoroughly familiar with the surgical procedure, instruments and implant characteristics prior to performing surgery.Per the stg: "improper selection, placement, positioning and fixation of these devices may result in unusual stress conditions reducing the service life of the implant".Inappropriate or improper surgical placement of this device may cause distraction or stress shielding of the graft or fusion mass.This may contribute to failure of an adequate fusion mass to form.
 
Event Description
Through journal article 'dynamic versus rigid stabilization for the treatment of disc degeneration in the lumbar spine' in evidence-based spine-care journal, volume 2: issue 3 (2011), it was reported that a patient required reoperation due to "nerve root irritation and pain" attributed to "pedicle screw misplacement." after revision surgery, all fusions were solid with positive sentinel sign on x-ray at final follow-up.The study aimed to describe the outcome of stabilization surgery with dynamic instrumentation for degenerative disc disease.In total, the success rates of 25 patients treated with stabilization of the involved vertebral dynamic unit(s) with either dynamic or rigid instrumentation with or without additional decompression were analyzed.The dynamic group was implanted with non-stryker devices and the rigid group with stryker devices.The device information is reported as 'xia, stryker spine, allendale, new jersey, usa'; catalog and lot numbers are not provided.
 
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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 Key11610878
MDR Text Key243726191
Report Number3005525032-2021-00013
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K142381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SPN
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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