MAUDE Adverse Event Report: SYNTHES (USA); SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 04/04/2012

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identification and weight not available for reporting.This report is for one (1) unknown synex ii cage, unknown part # / lot #.(other number) udi # unknown part number, udi is unavailable.The investigation could not be completed; no conclusion could be drawn, as no product was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following literature article: s.Thambiraj et al.(2012).A novel ¿¿pelvic ring augmentation construct¿¿ for lumbo-pelvic reconstruction in tumour surgery, eur spine j (2012) 21:1797¿1803.United kingdom.The study objective was to reconstruct or augment the lumbo-pelvic junction after resection of l5 and part of the sacrum using a pelvic ring construct.The study was comprised of one (b)(6) year-old lady who presented with implant failure of her two previous posterior lumbo-pelvic reconstructions.She initially presented two and a half years previously with 6 months history of back pain with normal neurological function.Mri scans of her whole spine showed isolated secondaries in the lumbar spine (l4, l5) and sacrum (s1).An abdominal ct scan demonstrated a primary tumour in her right kidney.The first surgery involved a single stage removal of posterior elements of l4 and l5 and posterior stabilization from l2 to pelvis including screws for s1/2 followed by right nephrectomy, anterior resection of l4 and l5 and partially s1 with implantation of an expandable synex ii cage.The cage dislodged from the sacrum within the first postoperative week and subsequent revision was performed with an anterior rod construct from l2 and l3 to a trans-sacral screw.The synex ii cage was removed.The manufacturer of the rod and screw construct is unknown.Postoperatively, she suffered temporary tetra-paresis.All investigations, however, were unremarkable and she recovered completely.The second revision procedure was performed 9 months later.The manufacturer of these devices is unknown.This involved removal of two posterior broken rods which were replaced and converted into a modified four rod construct by adding two more rods and extending from t12 to an additional set of pelvic screws.While monitoring her progress, it was subsequently noted that the trans-sacral rod had broken.Therefore, it was decided to augment her lumbo-pelvic construct to prevent eventual catastrophic posterior construct failure.From a posterior approach, contoured rods were passed bilaterally along the inner table of the pelvis under the iliacus muscle up to the anterior border of the pelvis.Using t-connectors, the rods were connected to the posterior lumbo-pelvic construct.Thereafter, two anterior supra-acetabular pelvic screws were connected to a subcutaneously placed rod matched to the shape of the anterior abdominal wall.The pelvic ring construct was completed on connecting this rod with t-connectors to the free ends of the contoured iliac rods.The manufacturer of these devices is unknown.There were no intra-operative complications.At the end of 12 months, she was mobilizing with a frame, with no radiological evidence of failure of the construct.However, she died due to disease progression at the end of 15 months.Author provided additional information on october 10, 2017, stating that there was no malfunction, just a technical note.The following complications were reported: one female patient, age (b)(6), had a synex ii cage dislodged from the sacrum within the first postoperative week and a subsequent revision was performed with an anterior rod construct from l2 and l3 to a trans-sacral screw.The synex ii cage was removed.The manufacturer of the rod and screw construct is unknown.At the end of 12 months, she was mobilizing with a frame, with no radiological evidence of failure of the construct.This is report 1 of 1 for (b)(4).This report is for one (1) unknown synex ii cage, unknown part # / lot #.

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6961344
• MDR Text Key: 89713681
• Report Number: 2520274-2017-12477
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/19/2017
• 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
• Patient Age: 69 YR