MAUDE Adverse Event Report: XTANT MEDICAL CALIX LUMBAR SPINAL IMPLANT SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	X034-0241-PC-STR
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-ray images that identified loosening of the implant construct were not provided for the complaint investigation.A revision procedure was performed on (b)(6) 2020.There were no reported complications or delay in treatment associated with the revision procedure.On 10/14/2020 a response from the complainant, who identified that in addition a migrated locking cap, the system rod and interbody spacer had migrated resulting in a patient dura tear.It may be possible for a locking cap to migrate from the original procedure implant construct location if the torque applied to the locking cap was not enough for appropriate final locking.The company confirmed that the torque limiting handles that were used during the original procedure effectively limited applied torque as intended.A locking cap could become loose and migrate if the implant construct was subjected to inordinate stress prior to maturation of the fusion mass was confirmed.Through the course of the investigation, the complainant also reported that the system rod and interbody spacer had migrated resulting in a patient dura tear.If any component of an implant construct becomes loose, it may allow shifting/loosening of other implant components resulting in implant migration.The potential complications and adverse effects section of the pedicle screw ifu includes early or late loosening of the components; disassembly, bending or breakage of any or all of the components; non-union (pseudarthrosis); and dural tears.The potential complications and adverse effects section of the interbody spacer ifu includes early or late loosening of any or all of the components; dural tears, persistent csf leakage, meningitis; non-union (pseudarthrosis), and delayed union, mal-union.
Event or Problem Description
The company received notification of 9/24/2020 from a surgical facility, that reported during a patient's routine eight-month follow-up an implant locking cap was identified as having migrated since the original procedure.The original l5-s1 decompression and fusion with pedicle screws and interbody spacer was performed on (b)(6) 2020 due to personal injury.There were no known patient complications identified during the original procedure.The health status of the patient was reported as, "patient's general health is well.However, patient is experiencing great pain when standing, sitting, and walking." the following reports are associated with this submission: 3005031160-2020-00023 and 3005031160-2020-00026.

• Brand Name: CALIX LUMBAR SPINAL IMPLANT SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 10802951
• Report Number: 3005031160-2020-00027
• Device Sequence Number: 11501598
• Product Code: MAX
• UDI-Device Identifier: M697X0340241PCSTR1
• UDI-Public: M697X0340241PCSTR1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: X034-0241-PC-STR
• Device Lot Number: 061547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 11/06/2020
• 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: 82