MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number UNK_SPN

Device Problem Migration (4003)

Patient Problems Neuropathy (1983); Injury (2348)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

It was reported that a tritanium pl cage migrated post-operatively and caused l5 root problems.Revision surgery has occurred, and the plate remains implanted.

Manufacturer Narrative

Visual, dimensional, material, and functional analysis could not be performed as the device was not returned because it remains implanted in the patient.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.There is not enough information provided to determine a root cause.Multiple attempts were made to collect additional information but no response was received.No x rays, surgical notes, or photos were provided.It is unknown what supplemental fixation was used, what the surgeon's technique was, if there were any complications, or the patient's activity level or bone quality.

Event Description

It was reported that a tritanium pl cage migrated post-operatively and caused l5 root problems.Revision surgery has occurred, and the plate remains implanted.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9950059
• MDR Text Key: 187422479
• Report Number: 3004024955-2020-00007
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K181014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• 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: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention