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

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown syncage/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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: yan, s.Z., di., j., and shen, y.(2017), adjacent segment degeneration following anterior cervical discectomy and fusion versus the bryan cervical disc arthroplasty, medical science monitor, vol.23, pages 2692-2700 (china).The aim of this study was to investigate the risk factors for adjacent segment degeneration following acdf compared with the use of the bryan artificial disc for cervical disc arthroplasty (cda).From december 2002 to december 2004, a total of 39 patients (24 males and 15 females) who underwent anterior cervical discectomy and fusion using the syncage-c (synthes co.).All patients were required to complete clinical and radiological evaluation before surgery, and at three days, three months, one year, and three years postoperatively, with the last follow-up at more than 96 months.The following complications were reported as follows: 19 patients had adjacent segment degeneration.Follow-up x-rays showed solid fusion with an absence of movement in all but one case (at 13-month follow-up), who showed slight movement in the operated level despite clinical improvement.This report is for a syncage-c (synthes co.).This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: SYNCAGE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• 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: 9676891
• MDR Text Key: 189497691
• Report Number: 8030965-2020-00901
• Device Sequence Number: 1
• Product Code: OVE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• 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
• Date Manufacturer Received: 01/15/2020
• 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