MAUDE Adverse Event Report: LIFE SPINE DYNA-LINK BARB; INTERVERTEBRAL BODY FUSION DEVICE

Model Number 83-005

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

The implant was not retrieved by life spine, therefore, without further information the root cause of the reported issue could not be identified.However, it is hypothesized that the reported event may have occured due to the barbs not being appropriately seated inside the pocket of the implant and/or cam lock not being turned using the provided torque handle in the set.Additionally, one contributing factor to the failure could be that the patient had poor bone quality, which might compromise the stability of the barbs in engaging into the bone.

Event Description

It was reported that the barbs had migrated discovered post op.The barbs were removed and screws placed on (b)(6) 2024.

• Brand Name: DYNA-LINK BARB
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 18576502
• MDR Text Key: 333658866
• Report Number: 3004499989-2024-00001
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00190837155131
• UDI-Public: 00190837155131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 83-005
• Device Lot Number: EM90195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male