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

Catalog Number UNK_SPN

Device Problem Insufficient Information (3190)

Patient Problem Spinal Cord Injury (2432)

Event Date 05/01/2013

Event Type  Injury  

Event Description

The article 'hybrid technique for posterior lumbar interbody fusion: a combination of open decompression and percutaneous pedicle screw fixation' in orthopaedic surgery, volume 5, number 2, may 2013, was reviewed.The authors describe a hybrid technique that involves a combination of open decompression and and percutaneously inserted pedicle screws.From 2007 to 2011, a series of patients with grade i-ii spondylolisthesis at l4 to l5 and moderate to severe canal/foraminal stenosis underwent midline posterior lumbar interbody fusion (plif).Inclusion criteria for this study were patients aged 35 to 75 years with degenerative spondylolisthesis grade 1 or 2.All patients presented with either back pain, radiculopathy, claudication or a combination of these three symptoms.All patients had pain resistant to prolonged (at least six months) conservative therapy.The authors compare a standard open decompression and fusion technique with a minimally invasive hybrid technique.The minimally invasive technique resulted in shorter hospital stay, earlier mobilization and reduced postoperative narcotic usage.The long-term clinical outcomes were equivalent in the two groups.The serengeti and mantis systems were used.The minimally invasive technique had a significantly lower complication rate than the conventional open technique.There were two cases of infection with the open technique in comparison to one with the mis technique (utis, no wound infections).One patient in the open cohort experienced deep vein thrombosis.One member of the minimally invasive group developed a painful hematoma postoperatively and presented with sacral and bilateral leg numbness.Motor function remained intact.One patient in the open cohort also experienced postoperative radiculopathy.These patients were observed without treatment and their radiculopathy improved with time, however they did experience long-term sensory impairment.There were also three cases of postoperative paralytic ileus, identified after complaints of nausea and vomiting, in the open group.With regard to these events, there are no allegations of stryker device malfunction.Absent direct claim by the authors, it is reasonable to conclude that the stryker devices did not cause or contribute to these events.These events are common and well-documented sequelae associated with spine surgery and are not attributable to a stryker device.One member of the open group had a dural tear and experienced headaches and vomiting following the procedure, which prolonged their length of stay.

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: 19215770
• MDR Text Key: 341422328
• Report Number: 0009617544-2024-00057
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/01/2024
• 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