MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of event: odate, s; et al (2016) hybrid decompression and fixation technique versus plated 3-vertebra corpectomy for 4-segment cervical myelopathy analysis of 81 cases with a minimum 2-year follow-up.Clin spine surg, vol:29(6), 226-233.(japan).This report is for one (1) unknown cage/spacer.Part#, lot# and udi # is not available.Implanted, explanted dates: unknown.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown cage/spacer.Pma/510(k) number is not available.Product was not returned and no lot number was provided.Based on the information available, 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.(b)(4).

Event Description

This report is being filed after subsequent review of the following literature article: odate, s; et al (2016) hybrid decompression and fixation technique versus plated 3-vertebra corpectomy for 4-segment cervical myelopathy analysis of 81 cases with a minimum 2-year follow-up.Clin spine surg, vol:29(6), 226-233.(japan) the purpose of this study was to compare the stability and outcomes of a hybrid technique with those of a 3-vertebra corpectomy in the management of 4-segment cervical myelopathy.A total of 81 patients (64 men and 17 women) between 2006 and 2010 had undergone an anterior procedure for 4-segment cervical myelopathy were accepted in the study.The patients were classified into 2 groups on the basis of the type of surgery used: the hybrid group was treated with a plated 2-vertebra corpectomy and adjacent single-level discectomy with stand-alone cage fixation, and the corpectomy group was treated with a plated 3-vertebra corpectomy.The corpectomy segments were reconstructed and fused using autologous fibular strut grafts and an anterior cervical plate (atlantis plate; medtronic sofamor danek, memphis, tn).The discectomized segments were reconstructed and fused using an intervertebral titanium cage (syncage; synthes, luzern, switzerland) without plate fixation.Locally minced bone from the resected vertebral bodies was packed into the cage.Postoperative c5 palsy developed in 8 patients of the corpectomy group and in only 1 patient of the hybrid group.Donor-site pain developed in both the groups (4 in the corpectomy group and 2 in the hybrid group.Adjacent segmental disease (2 disc herniation and 1 foraminal stenosis) developed in 3 patients in the corpectomy group and in 2 patients (disk herniation) in the hybrid group.Conservative treatment including neurotropic drugs was used for these patients.This report is 1 of 1 for (b)(4).This report is for an unknown syncage.This report is for 1 unknown patient who experienced c5 palsy, 2 had persistent donor site pain and 2 had adjacent segment disease (disk herniation).

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7100022
• MDR Text Key: 94257109
• Report Number: 8030965-2017-50449
• Device Sequence Number: 1
• Product Code: OVE
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/09/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention