MAUDE Adverse Event Report: SPINAL ELEMENTS, INC SAPPHIRE; ANTERIOR CERVICAL PLATE SYSTEM

Model Number 27040-014

Device Problems Fracture (1260); Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

Radiographs received confirmed the event.Images depicted the left bone screw backing out of c7 and fractured post operatively during the four years.The upper half of two broken screws were returned, measured and met dimensional specifications.Review of dhr cannot be completed as the lot number cannot be read (surface damage).Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, the longevity the degree of post lateral pseudarthrosis or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported).Root cause is likely the four year duration and patient's pseudarthrosis.

Event Description

On (b)(6) 2016, patient underwent anterior cervical fusion (acdf) surgery with a two level anterior cervical plate (acp) c5-c7.Patient had pseudoarthrosis/non-fusion.Reportedly on (b)(6) 2022, radiographs depicted the left c7 bone screw on the acp had backed out and then fractured.On (b)(6) 2022 revision surgery was performed to replace the construct.

• Brand Name: SAPPHIRE
• Type of Device: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 13515921
• MDR Text Key: 286672845
• Report Number: 3004893332-2022-00002
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00840606107990
• UDI-Public: 00840606107990
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040-014
• Device Catalogue Number: 27240-014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention