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

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Osteolysis (2377); Decreased Sensitivity (2683); Joint Laxity (4526); Insufficient Information (4580)

Event Type  Injury  

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 in 183 patients (60 males, 126 females) for vbs implants against all other surgical cases recorded within the spine tango registry between 2012 to 2023.The following complications were reported: intra-operative general complications -1 anaesthesiological intra-operative surgical complications -3 other post-operative general complications before discharge -1 cerebral -1 death post-operative surgical complications before discharge -1 radiculopathy -1 motor dysfunction -1 sensory dysfunction postoperative complications -1 sensory dysfunction -1 motor dysfunction -2 adjac.Segment pathology -3 fracture vertebral structures -1 other reoperations: 12 reoperations at any level -1 hardware removal -1 instability -1 failure to reach therapeutic goals -1 implant failure -1 neurocompression -10 unknown 5 reoperations at an adjacent level -1 hardware removal -1 instability -1 failure to reach therapeutic goals -1 implant failure -1 neurocompression -3 unknown 2 reoperations at the same level -1 hardware removal -1 instability -1 failure to reach therapeutic goals -1 implant failure -1 unknown this is for depuy spine confidence cement.This is report 2 of 2 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.G4-510k: this report is for an unknown biomaterial - cement: confidence/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.E3: reporter is a j&j employee.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: 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 (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 18483674
• MDR Text Key: 332552534
• Report Number: 1526439-2024-00562
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• 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: 01/10/2024
• 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: 12/21/2023
• 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