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

Catalog Number UNK_SPN

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Injury (2348)

Event Date 02/04/2019

Event Type  Injury  

Event Description

Due to the malposition of the screw during initial surgery on (b)(6) 2019, the patient had to be revised from a 6.5mm screw to a 7.5mm screw on (b)(6) 2019.

Event Description

Due to the malposition of the screw during initial surgery on 02 apr 2019, the patient had to be revised from a 6.5mm screw to a 7.5mm screw on (b)(6) 2019.

Manufacturer Narrative

It was reported that an unspecified 6.5 mm screw was noted to be "malpositioned" and was replaced with a 7.5 mm screw in a revision surgery.The screw was not returned for evaluation and the lot number is unknown so manufacturing record review could not be performed.Visual, dimensional, material analysis and functional analysis could not be performed as the device was not returned.A review of the device history records could not be performed as a valid lot code was not provided and could not be obtained.A complaint history review for similar events for the manufacturing lot could not be performed because the device associated with this event was not returned nor was a valid lot number provided.The device was not at an undesirable angle, the device did not back out, and the surgeon was not aware of why this happened 3 weeks after surgery.Per the xia ifu the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.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.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the devices.Bending, disassembly or fracture of any or all implant components can occur.Fatigue fracture of spinal fixation devices, including screws and rods, has occurred.Loosening of spinal fixation implants can occur.Based on the lack of information received and a device to evaluate, root cause cannot be determined.If more information becomes available in the future, this investigation will be reopened and updated accordingly.H3 other text : device was not returned and therefore could not be evaluated.

Manufacturer Narrative

The h6 code grids have been updated.

Event Description

Due to the malposition of the screw during initial surgery on (b)(6) 2019, the patient had to be revised from a 6.5mm screw.To a 7.5mm screw on (b)(6) 2019.

• 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: 8633795
• MDR Text Key: 145905992
• Report Number: 3004024955-2019-00014
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 08/15/2019; 08/15/2019
• Supplement Dates FDA Received: 09/12/2019; 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention