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

Model Number	10-03-6550-2
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiograph received confirmed the reported event.No product was returned, no product information was given, and no further evaluation of the product can be completed at this time.Patient's activity at the time or prior to the event, patient's compliance with post-operative care instructions, patient's bone quality, and the degree of spinal instability are all unknown.It was reported that the patient did not sustained a fall/impact/trama at the time of the event.Though the devices were loaded for 19 months, and cyclical fatigue may occur with nonunion; the root cause cannot be determined.Review of labeling notes.Possible adverse effects: potential adverse effects may include, but are not limited to the following: · bending, disassembly, or fracture of any or all implant components.·delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending, or fatigue fracture.
Event or Problem Description
On (b)(6) 2016, patient underwent single level spinal fusion surgery to fuse l4-l5.Patient received an interbody device and bilateral posterior fixation.On (b)(6) 2017 radiograph noted that the patient had possible osteolyisis near the tips of the pedicle screws at l4.The l4 vertebral body had grade one spondylolisthesis and the l5 pedicle screws had fractured approximately at the second thread below the shank head.Revision surgery was performed to replace the screws.

• Brand Name: SAVANNAH
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS; 1755 west oak parkway; marietta GA 30062
• MDR Report Key: 7610113
• Report Number: 1067095-2018-00002
• Device Sequence Number: 19241977
• Product Code: NKB
• UDI-Device Identifier: 00840916102173
• UDI-Public: 00840916102173
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2018

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: Physician
• Device Model Number: 10-03-6550-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 06/18/2018
• 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