MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CAGE/SPACERS: SYNCAGE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problems Break (1069); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 11/01/2012

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cage/ spacers: syncage/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.Product was not returned.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.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 the review of the following journal article: liu, y.Et al (2012), comparison of 3 reconstructive techniques in the surgical management of multilevel cervical spondylotic myelopathy, spine, vol.37 (23), pages e1450¿e1458, doi: 10.1097/brs.0b013e31826c72b4, (china).The aim of this retrospective comparative study is to compare the clinical effects, radiological parameters, and complications between the hybrid decompression (1-level corpectomy plus 1-level discectomy), 3-level discectomy, and 2-level corpectomy in treating patients with 3-level csm.Between january 2003 to july 2010, a total of 180 patients with a mean age of 46.7 years (range, 31-74 years) underwent multilevel anterior cervical procedures.These patients were grouped into 3 according to the procedures performed: 69 patients (39 male and 30 female) with a mean age of 46.1 ± 6.8 years (31¿74 years) underwent anterior cervical discectomy and fusion (acdf) using syncage (synthes, mezzovico-vira, switzerland) and a plate from a competitor; 72 patients (44 male and 28 female) with a mean age of 46.9 ± 7.1 years (33¿71 years) underwent hybrid decompression and fusion (hdf); 39 patients (26 male and 13 female) 47.8 ± 6.4 years (31¿72 years) underwent anterior cervical corpectomy and fusion (accf) using cage and plate from a competitor.After surgeries, the radiological examinations were obtained on day 1, and then at 3- and 6-month follow-ups.The subsequent follow-up examinations were performed at every 6-month interval.The overall follow-up period of the patients ranged from 11 to 40 months (average 26.1 months).The following complications were reported as follows: acdf group: 9 patients had fair result according to odom criteria.2 patients had bad result according to odom criteria.1 patient had cerebral fluid leakage.1 patient had epidural hematoma.2 patients had c5 palsy.3 patients had hoarseness.8 patients had dysphagia.Hybrid group: 10 patients had fair result according to odom criteria.2 patients had bad result according to odom criteria.Fusion rate is only 94.4%.1 patient had infection.2 patients had hoarseness.2 patients had c5 palsy.7 patients had dysphagia.1 patient had hardware breakage.1 patient had subsidence.2 patients had graft dislodgment.This report is for an unknown synthes syncage.It captures the reported events of hardware breakage, subsidence and graft dislodgment.This is report 2 of 2 for complaint (b)(4).

• Brand Name: UNK - CAGE/SPACERS: SYNCAGE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9662426
• MDR Text Key: 190476557
• Report Number: 8030965-2020-00806
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• 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?: Yes
• Date Manufacturer Received: 01/14/2020
• 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