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

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

Patient Problems Failure of Implant (1924); Nerve Damage (1979); Decreased Sensitivity (2683); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown biomaterial - cement/ 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Patient code (b)(4) used to capture additional medical/surgical intervention required.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 (b)(6) as follows: this report is being filed after the review of spine tango registry report: implant report for depuy synthes vbs implants: euro spine tango (2020),spine tango registry, pages 1-40 ((b)(6)).This report aims to compare usage and outcomes recorded for vbs implants against all other surgical cases recorded within the spine tango registry.Between 16 january 2012 and 30 november 2020, a total of 292 patients (148 males, 145 females) were evaluated to compare usage and outcomes for vbs implants against all other surgical cases recorded within the spine tango registry.The following complications were reported: general complications- postoperative surgical before discharge: 1 death.General complications- postoperative surgical before discharge: 1 cerebral.Surgical complications- intraoperative adverse events: 2 other.Surgical complications- postoperative surgical before discharge: 1 radiculopathy, 1 motor dysfunction, 1 sensory dysfunction.Reoperations : number of reoperations at any level (9): 1 failure to reach therapeutic goals, 1 hardware removal, 1 implant failure,1 instability, 7 unknown.This is for depuy spine confidence cement.This complaint involves one (1) device.Related product complaint: (b)(4).This is report 1 of 1 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.H10 additional narrative: b5.G2.H6: health effect - clinical code and health effect - impact code.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 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 1 of 2 for (b)(4).

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11215800
• MDR Text Key: 233344472
• Report Number: 1526439-2021-00176
• 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: Other,Study,Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention