MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CAGE/SPACERS: SYNCAGE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patient involved.Implantation date unknown.This report is for an unk - cage/spacers: syncage/unknown lot.Part and lot numbers are unknown; udi 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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.

Event Description

Device report from (b)(6) reports an event as follows: this report is being filed after the review of the following journal article: stubig, t.Et al (2018), total disc replacement versus anterior-posterior interbody fusion in the lumbar spine and lumbosacral junction: a cost analysis, global spine journal, vol.8 (2), pages 129¿136, https://doi.Org/10.1177/2192568217713009 ((b)(6)).The aim of this prospective observational cohort study is to conduct a prospective cost-analysis comparing lumbar tdr and circumferential fusion surgery for discogenic lbp in adults in a tertiary referral spinal surgery center in the (b)(6).Between 2005 to 2008, a total of 75 patients with an average age of 41.9 ± 8.2 years, were included in the study.These patients were divided into 2 groups: a group of patients (fusion group) with anterior and posterior fusion using allograft and lamina screws from competitor or titanium cage (syncage; synthes, zuchwill, switzerland) and pedicle screws from a competitor in 38 patients, and a second group with tdr (tdr group) using prodisc (synthes, zuchwill, switzerland) in 37 patients.All patients were seen at 24-month follow-up.The following complications were reported as follows: fusion group: 5 patients received an injection therapy with a mean time of 12 ± 6 days to the first index procedure and hospital stay of further 6 days.4 patients underwent debridement due to hematoma or infection.1 patient underwent repair of a meningomyelocele.2 patients needing further posterior 2-level posterolateral fusions (l4 to s1).This report is for an unknown synthes syncage.A copy of the literature article is being submitted with this medwatch.This report is for (1) unk - cage/spacers: syncage.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: SYNCAGE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 10804896
• MDR Text Key: 217418931
• Report Number: 8030965-2020-08736
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10/13/2020
• Initial Date FDA Received: 11/06/2020
• 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