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

Model Number	27240-014
Medical Device Problem Codes	Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Neck Pain (2433)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiographs received confirming the event, depict bone screw backing out of c7 at 6 weeks.Review of dhr concluded that the product was inspected and accepted and met all specified parameters with no associated nonconformance.Device was returned with the locking mechanism disassembled from the bone screw.It is unknown if this disassembly was a result of the revision to remove and replace the device.The device met dimensional specifications.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, patient compliance with postoperative care instructions, or if the patient sustained a fall/impact of any sort or if the locking mechanism was deployed at the time of implantation.Root cause of specific failure mode cannot be determined.
Event or Problem Description
On (b)(6) 2021, patient underwent anterior cervical fusion (acdf) surgery with a two level anterior cervical plate (acp) c5-c7 and was fine at three week follow up.Reportedly on (b)(6) 2021, radiographs depicted the left c7 bone screw on the acp had backed out.Patient throat irritation and neck pain.On (b)(6) 2021 revision surgery was performed to replace the c7 screw.

• 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: 13054433
• Report Number: 3004893332-2021-00025
• Device Sequence Number: 3887685
• Product Code: KWQ
• UDI-Device Identifier: 00840606108546
• UDI-Public: (01)00840606108546(10)210110(11)210610
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/21/2021

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: 27240-014
• Device Catalogue Number: 24240-014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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