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

Model Number	27040-014
Medical Device Problem Codes	Fracture (1260); Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004893332-2022-00002
• Device Sequence Number: 4159107
• Product Code: KWQ
• UDI-Device Identifier: 00840606107990
• UDI-Public: 00840606107990
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K101848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown