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

Catalog Number UNK_SPN

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026); Migration (4003)

Patient Problem Injury (2348)

Event Date 07/16/2019

Event Type  Injury  

Event Description

It was reported the surgeon confirmed via x-ray that a serrato screw "erupted" post operatively.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.The patient had normal post-op activity, did not fall, there were no complications in the initial surgery, and the patient had normal bone quality.The surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.While the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone as the device was not returned and no x rays or images were provided, a root cause cannot be determined.Possible root causes based on the information provided and the risk table include poor fixation construct, improper screw hole prep, improper screw insertion, screw too proud, and/or improper rod contouring.Additionally, according to the ifu, early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis, or trauma.H3 other text : status and location of the device are currently unknown.

Event Description

It was reported the surgeon confirmed via x-ray that a serrato screw "erupted" post operatively.

• 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: 8828013
• MDR Text Key: 152310059
• Report Number: 3004024955-2019-00032
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR