MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT; CEMENT, BONE, VERTEBROPLASTY

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported the patient underwent a posterior lumbar spinal fusion (th9-l1) for th11 fracture on (b)(6)2023.In the surgery, th9-l1 fusion was performed with viper prime fenestrated screw.The surgeon performed cement reinforcement with the screw.The cement in question was injected into four screws of two vertebrae while the lateral images were checked as needed through continuous irradiation on the image.A frontal view revealed the cement leakage that could not be discerned from the side view.The cement movement was then checked intraoperatively several times with imagery, but there was no change in the cement movement.After the cement injection, the set screw final fastening was done after waiting fifteen (15) minutes for curing.This report is related to (b)(4) which captured the depuyspine screw.This report is for synthesspine cement.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: d1, d2, d3, d4, g4-510k: this report is for an unknown spine cement/unknown lot.Part and lot number are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a depuysynthes 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.

• Brand Name: UNK - BIOMATERIAL - CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• 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: 18384084
• MDR Text Key: 331499117
• Report Number: 8030965-2023-16090
• Device Sequence Number: 1
• Product Code: NDN
• 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: 12/22/2023
• 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: 12/01/2023
• 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