MAUDE Adverse Event Report: SPINAL ELEMENTS, INC SAVANNAH; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	10-02-6540-2
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent plif surgery prior to february 2016 (based on historical sales data) to fuse l5-s1.Recently patient had low back pain radiating to bilateral lower extremities.On (b)(6) 2022 ct noted spondylolisthesis at l4-l5 and moderate central stenosis.Radiographs depicted bilateral screw fractures at s1.Patient had fused l5-s1, but was revised for adjacent segment disease, involving l3-l5 alif, l4-l5 laminectomy, and l3-l5 posterior fusion.
Additional Manufacturer Narrative
During the review of dhr for lot #12-00407 and 100998, it was concluded that the product was inspected and accepted for use with no associated nonconformance specific to this product issue.Returned device was visually inspected, functionally tested and the complaint was confirmed.The devices were fractured approximately three threads from the neck.The returned devices otherwise meet dimensional specifications except in damaged areas which could not be measured.Though the segment is fused, the screws fractured during the six years of implantation.It is inconclusive if subsequent surgical intervention was required as the segment was reportedly fused.Unknown factors include: the effects of implant duration of six years, the progression towards spinal fusion when the event occurred, the degree of spinal instability, patient activity at the time or prior to the event, patient bone quality or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort.Root cause or specific failure mode cannot be determined.

• Brand Name: SAVANNAH
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW 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: 15504726
• Report Number: 3004893332-2022-00012
• Device Sequence Number: 8132894
• Product Code: NKB
• UDI-Device Identifier: 00840916101947
• UDI-Public: 00840916101947
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152920
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10-02-6540-2
• Device Catalogue Number: 10-02-6540-2
• Device Lot Number: 100998_12-00407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2012
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White