MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ATLAS CABLE SYSTEM

Model Number MSB_UNK_ATLAS_CBL

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: ms b_unk_rod_solr, serial/lot #: unknown, product id: msb_unk_screw, serial/lot #: unknown.Neither the device, nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Citation : bogie r, et al.The use of metal sublaminar wires in modern growth-guidance scoliosis surgery: a report of 4 cases and literature review.International journal of spine surgery, vol.14, no.2, 2020, pp.182¿188.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in a literature titled, 'the use of metal sublaminar wires in modern growth-guidance scoliosis surgery'.Summary : patients with progressive neuromuscular scoliosis were treated with a posterior stabilization.A fusionless growth-guidance instrumentation was used consisting of a combination of lumbar pedicle screws and sliding ti sublaminar cables along cobalt chrome rods.The instrumentation failed due to upper thoracic sublaminar wire breakage.The ongoing abrasion of the rod-wire interface caused severe metallosis.In these cases, a debridement and revision surgery was performed with partial fusion of the spine.Reported event : a (b)(6) year-old girl with severe neuromuscular scoliosis (congenital myopathy) presented with a progressive thoraco-lumbar curve.In (b)(6) 2012, a posterior stabilization and correction was performed using a hybrid system consisting of lumbar pedicle screws (l3¿l5) and 2 4.75-mm cobalt chrome (cocr) rods along the curvature.Correction and fixation was achieved by gradually applying tension of ti sublaminar cables at lumbar and thoracic levels (t3¿l1).Postoperative radiographic control showed no signs of complications, and correction of the curve was satisfactory (cobb angle 33 degree).After 5 months, routine follow-up radiography revealed fracturing of 5 upper thoracic sublaminar cables with loss of correction of the curve (cobb angle 44 degree).The broken sublaminar ti cables were surrounded by severe metallosis, the ongoing abrasion of the rod-wire interface caused severe metallosis for which surgical debridement was performed.Revision surgery was performed with replacement of the proximal wires by hooks, and a spinal fusion at the thoracic level was performed.The postoperative course was uncomplicated, and curve correction was preserved at 3-year radiological follow-up (cobb angle 27 degree).In (b)(6) 2012, a (b)(6) year-old girl diagnosed with rett syndrome underwent a posterior spinal stabilization for a progressive thoraco-lumbar scoliosis with a cobb angle of 67 degree.A hybrid posterior instrumentation with bilateral pedicle screws in l4, l5, and s1 and cocr rods were used.At levels t4¿l3, sublaminar atlas cables were attached to the rods.Curve correction and implant positioning were satisfactory (cobb angle 44 degree).The postoperative course was uneventful.After 1-year follow-up, the patient complained of back pain without neurological signs or symptoms.The radiographs revealed 2 broken sublaminar cables (level t4 and t5) with resulting loss of curve correction (cobb angle 60 degree).During revision surgery, metallosis was observed in the surrounding tissue and debrided at the site of the broken cables.These sublaminar cables were removed and replaced with transverse process hooks, and a spinal fusion was performed at the thoracic levels.After 4-year follow-up, instrumentation and curve correction were unaffected.As a result of fusion of the spine and placement of the transverse process hooks, no residual growth of the instrumented spine was observed.

• Brand Name: ATLAS CABLE SYSTEM
• Type of Device: CABLE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10763834
• MDR Text Key: 216119876
• Report Number: 1030489-2020-01519
• Device Sequence Number: 1
• Product Code: ISN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_ATLAS_CBL
• Device Catalogue Number: MSB_UNK_ATLAS_CBL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR