MAUDE Adverse Event Report: K2M, INC. UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPN

Device Problem Migration (4003)

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

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Device location unknown.

Event Description

The article 'endoscopic transforaminal decompression, interbody fusion, and percutaneous pedicle screw implantation of the lumbar spine: a case series report' in international journal of spine surgery, volume 6 (157-166) 2012, was reviewed.Sixty patients with diagnoses of degenerative disc disease, degenerative motion segments with stenosis, and spondylolisthesis, in whom nonoperative treatments failed, were treated with endoscopic transforaminal decompression and interbody fusion.Nineteen of the sixty patients were implanted with denali devices.The mean age was 52.8 years; thirty patients were female, thirty were male.The duration of illness averaged 5 years.There were nine patients who had ten prior lumbar surgical procedures: six had one-level decompressions, two had two-level decompressions, and one had an l5 to s1 fusion.Follow-up ranged from 6 to 25 months, with a mean of 12 months.The preoperative back pain score averaged 7.5 (range of 0 to 10) on the vas, and postoperative pain averaged 2 (range of 0 to 8) at the last follow-up.Preoperative back pain and leg pain were significantly reduced.Forty-seven imaging studies obtained at the last visit, including x-ray and computed tomography scans, showed solid fusion in 28 patients, stable fixation in 17, and osteolysis around the pedicle screws in 2.All patients had improvement of motor function.One patient experienced medial penetration of an s1 screw with s1 nerve root irritation.Revision surgery was required during the same admission.The patient had a satisfactory outcome after the second operation.One patient experienced pain related to loose pedicle screws and the hardware was removed.The patient had a satisfactory outcome after the second operation.

Manufacturer Narrative

The article 'endoscopic transforaminal decompression, interbody fusion, and percutaneous pedicle screw implantation of the lumbar spine: a case series report' in international journal of spine surgery, volume 6 (157-166) 2012, was reviewed.The devices were not returned for evaluation.Device history records and complaint history could not be reviewed without either the device or a valid lot number.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

Event Description

The article 'endoscopic transforaminal decompression, interbody fusion, and percutaneous pedicle screw implantation of the lumbar spine: a case series report' in international journal of spine surgery, volume 6 (157-166) 2012, was reviewed.Sixty patients with diagnoses of degenerative disc disease, degenerative motion segments with stenosis, and spondylolisthesis, in whom nonoperative treatments failed, were treated with endoscopic transforaminal decompression and interbody fusion.Nineteen of the sixty patients were implanted with denali devices.The mean age was 52.8 years; thirty patients were female, thirty were male.The duration of illness averaged 5 years.There were nine patients who had ten prior lumbar surgical procedures: six had one-level decompressions, two had two-level decompressions, and one had an l5 to s1 fusion.Follow-up ranged from 6 to 25 months, with a mean of 12 months.The preoperative back pain score averaged 7.5 (range of 0 to 10) on the vas, and postoperative pain averaged 2 (range of 0 to 8) at the last follow-up.Preoperative back pain and leg pain were significantly reduced.Forty-seven imaging studies obtained at the last visit, including x-ray and computed tomography scans, showed solid fusion in 28 patients, stable fixation in 17, and osteolysis around the pedicle screws in 2.All patients had improvement of motor function.One patient experienced medial penetration of an s1 screw with s1 nerve root irritation.Revision surgery was required during the same admission.The patient had a satisfactory outcome after the second operation.One patient experienced pain related to loose pedicle screws and the hardware was removed.The patient had a satisfactory outcome after the second operation.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12089203
• MDR Text Key: 269509032
• Report Number: 3004774118-2021-00196
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention