MAUDE Adverse Event Report: ELEVATION SPINE SABER-C SYSTEM; ANTERIOR CERVICAL INTEGRATED FIXATION SPACER SYSTEM

Model Number	CLP-01
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The removed spikes and locking plate implants were not returned but discarded at the facility as the surgeon felt the revision surgery was not a cause of the hardware.
Event or Problem Description
The patient's original operation occurred on (b)(6) 2024.In a post op follow-up, imaging showed what appeared to be the locking plate disassociated from its initial locked position on two saber-c spacers, and the spikes appeared to be migrating out of the spacer implant.A revision surgery occurred on (b)(6) 2024 in which the implanted saber-c locking plates and spike implants were removed from both the implanted spacers, but the spacers themselves were left implanted.Saber-c system bone screws were then used to fixate the spacers in place and new locking plates were used to complete the procedure.

• Brand Name: SABER-C SYSTEM
• Common Device Name: ANTERIOR CERVICAL INTEGRATED FIXATION SPACER SYSTEM
• Manufacturer (Section D): ELEVATION SPINE; 2511 garden road; suite b125; monterey CA 93940
• Manufacturer Contact: frank larosa ; 2511 garden road; suite b125; monterey, CA 93940
• MDR Report Key: 20321081
• Report Number: 3015991317-2024-00001
• Device Sequence Number: 7828447
• Product Code: OVE
• UDI-Device Identifier: 00810017910069
• UDI-Public: 00810017910069
• Combination Product (Y/N): N
• PMA/510(K) Number: K190885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: CLP-01
• Device Catalogue Number: CLP-01
• Device Lot Number: 12310-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SABER-C SPIKES, MODEL # CQ-12, LOT # AAA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male