MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH HIGH VISC CMW SPINAL CMT, 11CC; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 183901001

Device Problem Insufficient Information (3190)

Patient Problems Joint Laxity (4526); Insufficient Information (4580)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra): spine tango soa report - tlif.The following complications have been identified: failure to reach therapeutic goals, hardware removal, implant failure, spinal imbalance.Complication time/intervention.Repeat surgery.This is for depuy synthes spine confidence spinal cement system products (high visc cmw spinal cmt, 11cc (b)(4)).

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.A1 patient identifier: (b)(6).B3: unknown event date; study ranged several years.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter is j&j company representative.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.

• Brand Name: HIGH VISC CMW SPINAL CMT, 11CC
• 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 ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18466018
• MDR Text Key: 332328313
• Report Number: 1526439-2024-00429
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034455006
• UDI-Public: (01)10705034455006
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112907
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 183901001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/08/2024
• 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