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

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

Patient Problems Pulmonary Embolism (1498); Dysphagia/ Odynophagia (1815); Hematoma (1884); Unspecified Infection (1930); Speech Disorder (4415); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

The current report is a retrospective analysis of 391 patients (377 females, mean age 52 years) who underwent instrumentation skyline between 2013 and december 31, 2023.In 7 cases it was combined with synapse posterior.439 cases were combined with an intercorporal cage, of which there are 1 concorde, 2 cervios cage, 3 conduit tlif, 6 synmesh, 1 confidence cement, 88 conduit cervical, 67 syncage and 271 non-depuy brands.The conduit cervical (cc) cages in this cohort are part of a total of 210 cc cages of interest to analyze separately, so they will be excluded here.This leaves 391 cases for analysis.Complications were reported as follows: intra-operative complications: 3 patients had dural injury.1 patient had vocal cord dysfunction.2 patients had blood vessel injury.1 patient had hematoma.1 patient had esophagus injury.1 patient death.Post-op complications within 1 year: 85 patients had dysphagia.59 patients had vocal cord dysfunction.7 patients had surgical site infection.1 patient had pulmonary embolism.1 patient had thrombosis.Reasons for reoperations: 5 patients had hematoma drain.5 patients had redecompression.1 patient had revision of fusion.1 patient had drain of infection.1 patient had repair of dural injury.1 patient had reoperation due to other reasons.1 patient had 2nd reoperation to drain infection.This report is for unknown synthes cervios cage.This is report 5 of 7 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: CERVIOS
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18935506
• MDR Text Key: 338067226
• Report Number: 8030965-2024-03826
• Device Sequence Number: 1
• Product Code: MAX
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 03/11/2024
• 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