MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: CERVIOS; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

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

Patient Problem Unspecified Nervous System Problem (4426)

Event Type  Injury  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4 - 510k: this report is for an unknown cervios cage/unknown lot.Part and lot number are unknown; udi number is unknown.D6: date of implementation is an unknown date between 2011 and 2017.D9: complainant part is not expected to be returned for manufacturer review/investigation.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: 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.

Event Description

Device report from the united kingdom reports an event as follows: this report is being filed after the review of the following journal article: eseonu, k.Et al (2020), a retrospective comparative study of long-term outcomes following cervical total disc replacement versus anterior cervical discectomy and fusion, cureus 14(12), pages 1-8 (united kingdom).The aim of this retrospective study is to compare the short- and medium-term outcomes in adult patients (>18 years of age) undergoing total disc replacement (tdr) or acdf for cervical myelopathy or radiculopathy secondary to degenerative disc disease, as well as the incidence and causes of reoperation after both procedures.Between 2011 and 2017, a total of 244 patients (154 patients following single- and two-level acdfs and 90 single- and two-level tdrs performed by a single surgeon).There was no statistically significant difference in age (52.8 acdf vs.49.1 tdr; p > 0.05), gender distribution (48:52, male: female in the acdf group vs.49:51, male: female in the tdr group; p > 0.05), or length of follow-up between the two groups (the average in the acdf group was 63 months (range 24-96 months) compared with 57 months (24-90 months) in the tdr group).In addition, there was no statistical difference in the two-year follow-up rate between the two groups (93.3% acdf vs.94.6% tdr group, p > 0.05).The surgery was performed using a conventional left-sided anterior approach to the cervical spine.The symptomatic disc and then the posterior longitudinal ligament (pll) were excised.In the acdf group, the cervios synthes cage with local bone was implanted into the intervertebral space.In the tdr group, the prodisc-c vivo prosthesis was implanted after accurate measurement.The following complications were reported: acdf group: there were 2 cases that required reoperation (1.2%); one, the 41 year old, female who had adjacent segment degeneration identified clinically and radiographically at 24 month follow-up, and one, the 63 year old, female who had persistent myelopathic symptoms after the index procedure, which required posterior decompression (laminectomy) and stabilization.Tdr group: two cases of reoperation were identified in the tdr group (2.2%) as follows: the 45 year old, female who had reoperation identified and were performed two and five years after the index procedure due to adjacent segment degeneration; and the 23 year old, male who had reoperation due to adjacent segment degeneration.This report is for an unknown cervios cage.A copy of the literature article is being submitted with this report.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: CERVIOS
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16979695
• MDR Text Key: 315789746
• Report Number: 8030965-2023-06471
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• 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: 05/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female