MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREW/ROD CONSTRUCT ACCESSORIES: EXPEDIUM; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Deformity/ Disfigurement (2360); Osteolysis (2377)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown screw/rod construct accessories: expedium/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: nagamoto y., et al (2021) preoperative pelvic incidence minus lumbar lordosis mismatch in repeat posterior lumbar interbody fusion induces subsequent corrective long fusion, world neurosurg.Volume 154, pages e762-e769 (japan).This retrospective study aims to elucidate the clinical outcomes of repeat posterior lumbar interbody fusion (plif) by focusing on the relationship with spinopelvic parameters and the predisposing factors requiring subsequent corrective long fusion after repeat posterior lumbar interbody fusion (plif).From january 2002 to december 2018, 58 consecutive patients underwent a second single segment plif for adjacent segment disease (asd) following single-segment plif (repeat plif).Of the 58 eligible patients, 47 patients who had completed 2-year follow-up and had complete imaging data were included in this study.The study group included 20 men and 27 women, with a mean duration of follow-up of 4.3 years (range, 2e9 years).The mean age at repeat plif was 69.9 years (range, 41e84 years).The average duration between primary plif and repeat plif was 6.6 years (range, 0.3e17.8 years).The plif technique consisted of bilateral total facetectomy, subtotal discectomy, a large amount of autologous bone graft with 2 brantigan rectangular cages (depuy synthes spine, raynham, massachusetts, usa), and pedicle screw fixation using the steffee variable spine plating system (depuy synthes spine) in 12 early cases and the expedium spine system (depuy synthes spine).Interbody cages and block bones were placed anteriorly to obtain segmental lordosis.Range of follow-up (2e9 years after repeat plif, 2e22 years after primary plif).The following complications were reported as follows: deterioration occurred in 6 patients following repeat plif owing to further asd, and these patients underwent 19 additional surgeries.5 patients showed kyphotic deformity at the proximal or distal adjacent segment of the extended fusion mass following repeat plif and required corrective long fusion owing to poor sagittal alignment (please below): case no.6, 66-year-old female had l2 listhesis, l1 kyphotic fracture,.This patient underwent l2-3 posterior lumbar interbody fusion (plif), l1 vertebral column resection (vcr) , t4-l5 posterior spinal fusion (psf).This patient also had rod fracture at vertebral column resection (vcr) and underwent construct revision.Case no.8 , 71-year-old had l1-2 progressive kyphosis , l5-s kyphosis, and t3 listhesis.These were managed with l2 pedicle subtraction osteotomy (pso), t4-l5 , l5 pedicle subtraction osteotomy (pso), instrumented psf extended to pelvis, and instrumented psf extended to t1 respectively.Case no.13, 70-year-old female , had l2 kyphosis with huge hernia , l5-6 progressive kyphosis, and proximal junctional kyphosis.These were managed with l3 pedicle subtraction osteotomy (pso), t10-l6, l3 pedicle subtraction osteotomy (pso) and instrumented posterior spinal fusion (psf) extended to pelvis and instrumented psf extended to t4 respectively.Case no 33, 60-year-old female had l2-3 instability with collapse huge hernia, and proximal junctional kyphosis.There were managed with l2-3, l5-s posterior lumbar interbody fusion (plif), t8-p posterior spinal fusion (psf), and instrumented posterior spinal fusion (psf) extended to t4 respectively.Case no 47, 77-year-old male had l3-4 kyphosis and instability due to l5 pedicle fracture and distal implant failure.These were managed with instrumented posterior spinal fusion (psf) extended to l2 and l4 pedicle subtraction osteotomy (pso), l3-4 plif, t8-p posterior spinal fusion (psf) respectively.Case no.13 66-year-old woman, after the second plif, pi-ll remained poor.Only 5 months after the second plif, a large disc herniation at the proximal junction of the fusion mass with low lumbar lordosis occurred.Plif at l2-3 and pedicle subtraction osteotomy at l3 with pedicle screw fixation between t10 and l6 were performed.After the third surgery, a kyphotic deformity at the lumbosacral junction occurred.Plif at l5-6 and pedicle subtraction osteotomy at l6 with an extension of instrumented posterior fusion to the pelvis using an s2-alar-iliac screw were performed.After the fourth surgery, a proximal.Junctional kyphosis occurred.Instrumented posterior fusion was extended to t4.At the latest follow-up (10.9 years after the primary surgery), her global sagittal balance was maintained.She could walk using a cart without low back pain, although residual lower extremity weakness remained.This report is for unknown depuy synthes brantigan rectangular cages, unknown depuy synthes steffee variable spine plating system and unknown depuy spine expedium spine system.This is report 4 of 4 for (b)(4).

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES: EXPEDIUM
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14699276
• MDR Text Key: 294914735
• Report Number: 1526439-2022-00856
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention