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

Catalog Number UNK_SPN

Device Problems Biocompatibility (2886); Appropriate Term/Code Not Available (3191)

Patient Problem Neck Pain (2433)

Event Date 02/16/2007

Event Type  Injury  

Manufacturer Narrative

Current location of the device is unknown.

Event Description

A patient reported revision surgery to address, "persistent cervical and occipital pain.".

Event Description

A patient reported revision surgery to address, "persistent cervical and occipital pain.".

Manufacturer Narrative

Correction to b1.: adverse event and product problem has been changed to adverse event.Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history review could not performed as the device was not returned and the lot number was not provided.Per instrustruction for use: the surgeon must warn the patient of the surgical risks and made aware of possible adverse effects.Patients who smoke have been shown to have an increased incidence of nonunions.Surgeons must advise of this fact and warned of the potential consequences.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced a the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief.Foreign body sensitivity.Where material sensitivity is suspected appropriate tests must be made prior to materialimplantation.Contraindictions include: marked local inflammation.Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices.Bony abnormalities preventing safe screw fixation.Open wounds.Rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis.Osteoporosis or osteopenia are relative contraindications, since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.Metal sensitivity, documented or suspected.Pregnancy.Anytime implant utilization would interfere with anatomical structures or physiological performance.Inadequate tissue coverage over the operative site.No further investigation can be performed due to insufficient information provided.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.

• 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 Key: 8952733
• MDR Text Key: 160924325
• Report Number: 3004024955-2019-00035
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• 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
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR