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

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

Patient Problems Bone Fracture(s) (1870); Osteolysis (2377); Post Operative Wound Infection (2446); 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.D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown biomaterial - cement: confidence /unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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 synthes reports an event in switzerland as follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded for confidence implants in (b)(4) against all other surgical cases recorded within the spine tango registry between 2014 and 2024.Final registry report outcome description: general complications - intraoperative: 1 patient had anaesthesiological 3 patients had cardiovascular 1 patient had pulmonary 1 patient had thromboembolism 3 other.Surgical complications - intraoperative adverse events 1 patient had nerve root damage 26 patients had dural lesion 3 patients had fracture vertebral structures 7 other.General complications-postoperative surgical before discharge 1 patient had cardiovascular 3 patients had pulmonary 2 patients had cerebral 2 patients had liver/gi 1 patient had thromboembolism 3 other.Surgical complications - postoperative surgical before discharge 1 patient had csf leak/ pseudomeningocele 1 patient had sensory dysfunction 1 patient had wound infection superficial 3 patients had wound infection deep 5 other.Post operative complications: 1 patient had wound infection superficial 3 patients had adjac.Segment pathology 3 patients had fracture vertebral structures 1 other.Reoperations: -48 patients had reoperations at any level.-25 patients reoperations at same level.This report involves one unk - biomaterial - cement: confidence.This is report 5 of 5 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: CONFIDENCE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 18615503
• MDR Text Key: 334258204
• Report Number: 1526439-2024-00777
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/31/2024
• 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: 01/17/2024
• 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