MAUDE Adverse Event Report: DEPUY SPINE INC UNK - BIOMATERIAL - CEMENT: CONFIDENCE; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

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.B3: event occurred on an unknown date in (b)(6) of 2023.D1, d2, 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: initial reporter is a synthes 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 russia reports an event as follows: it was reported that during an unknown procedure in (b)(6) of 2023, there was an issue with the confidence cement.Water flowed out from the hydraulic pump.No further information is available.This report is for an unk - biomaterial - cement: confidence.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: CONFIDENCE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17879350
• MDR Text Key: 325022535
• Report Number: 1526439-2023-01943
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• 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