MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Improper Chemical Reaction (2952)

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

Event Date 02/10/2024

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales 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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was a balloon kyphoplasty for vertebral fracture on (b)(6) 2024, with the balloons, the cement and access kit in question.On (b)(6) 2024, the sales rep was informed that the removals of the balloons were difficult.In the surgery, after deflation of the balloon from the working sleeve, the balloon became stuck and the entire working sleeve was removed.The cement preparation was in progress at the same time, and the cement became hard and unusable due to the balloons stuck in the working sleeve.The cement was mixed again and the surgeon cemented.The cement needle, cement kit, and syringe kit in the access kit in question that have already hardened were not used.The surgery was completed successfully within 30 minutes surgical delay.Patient status/ outcome: stable no further information is available.This report is for one (1) unk - biomaterial - cement this is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18787457
• MDR Text Key: 336419603
• Report Number: 8030965-2024-02924
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/27/2024
• 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: 02/12/2024
• 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
• Treatment: SYNFLATE VERTEBRAL BALLOON MED.; SYNFLATE VERTEBRAL BALLOON MED.; SYNFLATE VERTEBRAL BALLOON MED.; UNK - ACCESS KITS.