MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPN

Device Problem Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 01/01/2011

Event Type  Injury  

Event Description

The 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, was reviewed.This study analyzed the success rates of(b)(4) with an average age of 47 years (43 to 51) treated with stabilization of the involved vertebral dynamic unit(s) with either dynamic or rigid instrumentation with or without additional decompression.Clinical outcome was assessed with oswestry disability index (odi) and visual analogue scale (vas) for back pain, leg pain, and activity level.Fusion rate and adjacent level(s) was checked with x-ray.Complications recorded in patients¿ files were evaluated and revision surgeries were stated as treatment failures.Dynamic stabilization was accomplished using a dynesys dorsal transpedicular device (non-stryker).Rigid stabilization was obtained by xia pedicle screw fixation and two interbody cages (stryker) per segment.The two groups did not differ significantly at baseline with respect to variables that were measured.The follow-up time for the dynamic group was 38 months (median range, 21¿60 months), and for the rigid group 53.5 months (median range, 25¿60 months).The involved discs in the dynamic group continued to degenerate.Adjacent segments showed loss of disc height in both groups but only loss of upper adjacent discs in the rigid group was statistically significant.Solid fusion was undoubtedly determined in seven patients from the rigid group.No obvious signs of non-fusion, eg, screw breakage or loosening, were noted on x-rays.No surgical complications (dural tear, nerve root lesion, wound infection or hematoma) were recorded in any patient.One patient implanted with xia devices underwent revision surgery to address a misplaced screw which resulted in post-operative nerve root irritation and pain.After revision surgery with rigid instrumentation, fusion was solid with positive sentinel sign on x-ray at final follow-up.

Manufacturer Narrative

H3 other text : device location unknown.

• 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-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19177508
• MDR Text Key: 340999838
• Report Number: 0009617544-2024-00055
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention