MAUDE Adverse Event Report: COLIGNE AG OSTAPEK VBR CAGE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 03/15/2019

Event Type  Injury  

Event Description

Literature cawley, derek t., et al., "carbon-fibre cage reconstruction in anterior cervical corpectomy for multilevel cervical spondylosis: mid-term outcomes" journal of spine surgery 5.2 (2019): 251 reports use of ostapek polycarbon-fiber vbr cage (coligne ag) in 17-63mm lengths for single and multilevel cervical corpectomy resulted in 20 cases of subsidence (28.6%), 9 severe subsidence (13%), one pt had a malpositioned cage requiring revision within 24 hours.One cage migration progressed over 6 weeks to ultimately require revision.One pt had a posteriorly malplaced cage requiring a posterior laminectomy at six weeks.Ostapek cage [k072328] designated non-cervical indication (mqp), device-use for cervical indications not fda-approved.Construct lengths of 63mm intended for non-fda approved multilevel cervical vertebral body replacement.Study fails to disclose use of device for cervical indications are not fda-approved.Device design rationale and instruments required to implant the device configured for anterior cervical spine use, yet labeling directs use in the thoracolumbar spine.Labeling is not consistent with design rationale, objective intent and manner in which device is actually put to use and sold for in the united states.Figure 2 shows cage dislocation when used for multilevel cervical vertebral body replacement.Fda safety report id# (b)(4).

• Brand Name: OSTAPEK VBR CAGE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): COLIGNE AG
• MDR Report Key: 9098077
• MDR Text Key: 159775883
• Report Number: MW5089921
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2019

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 82