MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - screws/unknown lot.Part and lot numbers are unknown; udi 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: kanbara s., et al (2020) impact of rigid fixation of the pubic symphysis for spinopelvic fixation in two cases of lumbosacral agenesis, spine surgery and related research, volume 4(4), pages 341-346 (japan).This study presents a case report of 2 patients of spinopelvic nonunion after lumbosacral fixation in which additional rigid fixation at the pubic symphysis resulted in bone union.A case of a (b)(6) male with klippel feil syndrome had a characteristic telescoping back.Was ambulatory, chief complaint being weakness in the right leg.Radiological images revealed a complete absence of the sacrum and incomplete formation of the lower lumbar vertebrae which descended into the gap between the ilia.At the age of (b)(6), he underwent t8-s posterior fixation with a spinal implant, followed by multiple augmentations using allografts at the lumbosacral junction.At the 1-year follow-up, the x-ray images revealed rod breakage and screw loosening due to nonunion at the spinopelvic junction.The broken implant was removed, followed by fixation using pedicle and iliac screws.Subsequently, because the posterior approach failed to achieve bone union again, bone graft augmentations were performed twice.However, bone union at the spinopelvic junction was still not achieved.Rigid fixation was done at the pubic symphysis with a small dynamic compression plate (dcp), creating a circumferential fixation of the pelvis months after the rigid fixation of the pubic symphysis, detected a fusion mass on the laminae, and bone union at the spinopelvic junction was achieved.He maintained an ambulatory status with the support of a single crutch at his final check-up, 8 years postoperatively.A case of a (b)(6) boy who had progressive spinal deformity.He had spinal dysraphism in addition to lumbosacral agenesis (renshaw iii) and a history of hydrocephalus and anal atresia.This had been treated surgically, and he had colostomy closure for anal atresia at the age of (b)(6).Underwent ventriculoperitoneal shunting for the treatment of hydrocephalus at the age of (b)(6).He had bilateral incomplete paraplegia of the lower limbs, and he moved mainly using his arms at home and a wheelchair outside.He could stand with the support of bilateral long leg braces.He had multiple hemivertebrae in the thoracic and lumbar segments, thoracic scoliosis of 78°, and lumbar scoliosis of 59°, with moderate lumbar kyphosis.On the 3d-ct images, the absence of bilateral sacroiliac joints was observed, with a residual structure of the first sacrum, which sank between the gaps of theilia.Diagnosed with lumbosacral agenesis, renshaw type iii.Growth-friendly surgery using bilateral rib-pelvis devices, vertical expandable prosthetic titanium ribs (veptr) was performed following halo-gravity traction at the age of (b)(6).After serial extension procedures (four times, with replacement three times, a combined two-stage anterior (l1-3) and posterior (t8-iliac) fixation with t9 wedge hemi vertebrectomy was performed with autologous bone graft between the lumbar vertebrae and the ilia bilaterally, using a rib graft, at the age of (b)(4) because of unreliable stability on the distal anchor fixation, we planned and performed additional fixation at the pubic symphysis with a small dcp 1 month after the posterior fixation followed by posterior augmentation with an allograft.These multiple procedures to create a rigid stabilization of the pelvic ring enabled complete bone union at the spinopelvic junction within a year of the operation.This report is for an unknown synthes vertical expandable prosthetic titanium ribs (veptr).This report is for (1)unk - screws.This is report 2 of 3 (b)(4).

• Brand Name: UNK - SCREWS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11352709
• MDR Text Key: 280444553
• Report Number: 8030965-2021-01123
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 3 YR