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

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

Patient Problems Nerve Damage (1979); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - cage/spacers: cervios/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Initial reporter is a j&j representative.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.The product was not returned.Based on the information available, it has been determined that no corrective and 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 synthes reports an event in (b)(6) as follows: the current report is a retrospective analysis of 133 patients (57 females and 76 males) who underwent instrumentation with cervios between january 02, 2006, and november 22, 2020.In 1 case it was combined with skyline.15 cases combined with anterior non-depuy devices were excluded, leaving 118 cases for analysis.Mean age of the patients was 51 years.Registered intra-operative complications: 1 dural tear.3 root injury.2 other.Reinterventions during index stay: 1 adjustment implant.Registered post-op complications within 1 year: 15 dysphagia.10 recurrent nerve injury.Readmissions: 1 redecompression.1 subsequent reoperation at a new index level.Global assessment of neck pain (ga) failure % : fu 1 yrs.49%, fu 2 yrs.48% fu 5 yrs.47% global assessment of arm pain (ga) failure % : fu 1 yrs.40%, fu 2 yrs.40% fu 5 yrs.47% this is for depuy synthes cervios.This report is for one (1) unk - cage/spacers: cervios.This is report 3 of 3 for complaint (b)(4).

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) "depuy spinal implants subreport 15 ¿ cervios" for a total of 151 patients who underwent instrumentation with cervios between (b)(6) 2006 and (b)(6) 2022.In 2 cases it was combined with skyline.15 cases combined with anterior non-depuy devices were excluded, leaving 136 cases for analysis.Mean age of the patients was 51 years.Complications reported in swedish spine registry (swespine) were: registered intra-operative complications (n=5): 1 dural tear; 1 hematoma; 1 root injury; 2 other.Registered post-op complications within 1 year (n=27): 16 dysphagia; 11 recurrent nerve injury.Reoperations (n=2): 1 adjustment implant; 1 redecompression.

• Brand Name: UNK - CAGE/SPACERS: CERVIOS
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12704013
• MDR Text Key: 283670736
• Report Number: 8030965-2021-09042
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention