MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. X-SPINE PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	N60001073
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complainant communicated on (b)(6) 2019 that a patient underwent a revision surgery on (b)(6) 2019 due to non-fusion and potential loosening hardware.The following mdrs are associated with this event: 3005031160-2019-00052, 3005031160-2019-00053, 3005031160-2019-00054, 3005031160-2019-00055, 3005031160-2019-00057, 3005031160-2019-00058, 3005031160-2019-00059, 3005031160-2019-00060, 3005031160-2019-00061, 3005031160-2019-00062, 3005031160-2019-00063.The complainant provided the following additional details.The patient had a plif at l4-5 on (b)(6) 2018 with good result for over a year but now has recurrent low back and right leg radicular pain.Her pain is severe enough that she cannot walk or get any activity.The pain radiates down into her medial malleolus and medial foot.Digital imaging done included four views of lumbar spine, ap and lateral in neutral, flexion and extension, which according to the surgeon, demonstrates five non-rib-bearing presacral vertebrae with no significant scoliosis.There has been a previous plif at l4-5 with pedicle screw fixation and a previous interbody fusion at l5-s1 without pedicle screw fixation.There is about a centimeter of retrolisthesis at l3-4.The patient had a lumbar ct study done (b)(6) 2019 which was reviewed by the surgeon, who believed showed lack of solid interbody fusion at l4-5 likely with loosening of the hardware.The patient had a lumbar mri study done on (b)(6) 2019 which was reviewed by the surgeon and demonstrates anterolisthesis at l4-5 which had developed since the previous mri study, as well as moderate stenosis at l3-4 somewhat improved from the previous study.The patient is having recurrent back and leg radicular pain, likely secondary to pseudarthrosis at l4-5 with recurrent stenosis at l3-4.The original procedure performed on (b)(6) 2018 was a plif at l4-l5 and bilateral hemi-facetectomies at l3-l4.Additional evaluation completed by the manufacturer indicated that the description of the patient's history and current pathology, does not indicate that the need for revision appears to be related to any failure or insufficiency of the hardware.For any number of reasons, the patient did not fuse as intended at l4-l5 from the previous procedure conducted on (b)(6) 2018.Any hardware loosening is likely due to the lack of fusion.Posterior fixation is indicated for use during the process of fusion and to provide fixation support to promote fusion.Without a solid fusion, the hardware may loosen or even fail over time.Additionally, the patient is exhibiting retrolisthesis and moderate stenosis at l3-l4 which is likely adjacent level disease caused by the stiffening of the l4-l5 level due to the instrumentation and attempted fusion but not specific to the hardware used." the post-operative management section of the associated instruction for use states that, "information on the procedure and patient should be retained to assist in any investigation." communication with the complainant was unable to successfully identify the lot numbers of the implants used for the (b)(6) 2018 procedure.The implants were not returned to the manufacturer for evaluation.Because of this, dhr reviews could not be performed during the complaint assessment.The ifu states that, "a successful result is not always achieved in every surgical case, especially in spinal surgery where many extenuating circumstances may compromise results." the combination of procedures and patient health status may be a factor to the lack of solid fusion.There is also a statement in the postoperative management section of the ifu that states, "if a non-union develops or the components loosen, bend, and/or break, the device(s) should be revised and/or removed immediately before serious injury occurs.Failure to immobilize a delayed or nonunion of bone will result in excessive and repeated stresses on the implant.By the mechanism of fatigue, these stresses can cause eventual bending, loosening or breakage of the device(s).".
Event or Problem Description
A complainant communicated on (b)(6) 2019 that a patient underwent a revision surgery on (b)(6) 2019 due to non-fusion and potential loosening hardware.The following mdrs are associated with this event: 3005031160-2019-00052, 3005031160-2019-00053, 3005031160-2019-00054, 3005031160-2019-00055, 3005031160-2019-00057, 3005031160-2019-00058, 3005031160-2019-00059, 3005031160-2019-00060, 3005031160-2019-00061, 3005031160-2019-00062, 3005031160-2019-00063.

• Brand Name: X-SPINE PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 9508001
• Report Number: 3005031160-2019-00056
• Device Sequence Number: 2086088
• Product Code: MNH
• UDI-Device Identifier: M697N600010731
• UDI-Public: M697N600010731
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K152132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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: N60001073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/20/2019
• 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: 80 YR