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

Model Number 27240-014

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

Patient Problems Failure of Implant (1924); Neck Pain (2433)

Event Date 11/19/2021

Event Type  Injury  

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 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
• 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: 13054433
• MDR Text Key: 284539320
• Report Number: 3004893332-2021-00025
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00840606108546
• UDI-Public: (01)00840606108546(10)210110(11)210610
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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