MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - BIOMATERIAL - CEMENT: CONFIDENCE; CEMENT, BONE, VERTEBROPLASTY

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

Patient Problems Hematoma (1884); Nerve Damage (1979); Perforation of Vessels (2135); Speech Disorder (4415); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown biomaterial - cement: confidence/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.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

The current report is a retrospective analysis of 93 patients (52 female) who underwent instrumentation skyline between january 02 2006 and november 22, 2020.In 3 cases it was combined with synapse posterior.71 cases were combined with an intracorporal cage, of which there are 1 concorde, 1 synmesh, 1 confidence cement and 68 non-depuy brands.Exclusion of non-depuy brands would reduce the sample to less than 25%, why decision was taken to analyze the whole sample.Mean age of the patients was 54 years.Intra-operative complications: -1 dural tear -1 recurrent nerve injury post-op complications within 1 year: -14 dyaphagia -11 recurrent nerve injury -1 ssi superficial readmissions: -2 drain hematoma -2 redecompression -1 revision of fusion global assessment of neck pain (ga) failure %: fu 1 yrs :37 fu 2 yrs :36 global assessment of arm pain (ga) failure % : fu 1 yrs: 44 fu 2 yrs: 52 this is for depuy spine skyline anterior cervical plate, confidence cement, and concorde.

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: b5, h6.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

Updated 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 (b)(6) 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 (b)(4) 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 depuy spine confidence cement this report captures the reported 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.

• Brand Name: UNK - BIOMATERIAL - CEMENT: CONFIDENCE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12733537
• MDR Text Key: 283166085
• Report Number: 1526439-2021-02301
• Device Sequence Number: 1
• Product Code: NDN
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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: 03/11/2024
• 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