MAUDE Adverse Event Report: SPINAL ELEMENTS, INC TALON; ORTHOSIS, SPINAL PEDICLE FIXATION

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

No clarifying details were provided.No further information was able to be received.Manufacturer could not be determined.The root cause is unknown, but possible pseudarthrosis can be a factor with a ten year implant duration.

Event Description

Received inquiry to determine unknown manufacturer of fractured s1 bone screws that was implanted ten years prior.Revision surgeon is different than the original surgeon.No medical records identifying implant manufacturer were provided and radiographs are inconclusive in determining the manufacturer.Revision surgery is speculated, however not confirmed.No further details about the event or the patient condition were provided.

• Brand Name: TALON
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad, ca
• Manufacturer Contact: mr perhach ; 3115 melrose drive; suite 200; carlsbad, ca ; 6071830
• MDR Report Key: 10012135
• MDR Text Key: 200481125
• Report Number: 3004893332-2020-00003
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 99