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

Model Number	26240-014
Medical Device Problem Codes	Loss of Osseointegration (2408); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr review cannot be completed at this time as the product was not returned and a lot number was not provided.The device was not returned as it was discarded and therefore could not be evaluated.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.Root cause of specific failure mode cannot be determined.
Event or Problem Description
On (b)(6) 2019 patient underwent cervical fusion surgery with a vbr at c6, single level acdf at c4-c5 and anterior cervical plate (acp) c4-c7.Reportedly on (b)(6) 2021 radiographs depicted the left c7 bone screw on the acp had backed out.On (b)(6) 2021 evision surgery was performed to replace the c7 screw and an additional stand-alone acdf at c3-c4.

• Brand Name: SAPPHIRE
• Common Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 11704042
• Report Number: 3004893332-2021-00002
• Device Sequence Number: 3909583
• Product Code: KWQ
• UDI-Device Identifier: 00840606107792
• UDI-Public: 00840606107792
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/30/2021

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: 26240-014
• Device Catalogue Number: 26240-014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 114