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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was a thoracolumbar posterior fusion for a th12 burst fracture on (b)(6) 2023.In the surgery, a posterior fusion (th11-l1), cement augmentation (th11/l1), and a vertebroplasty (th12) using biopex were done.Using an image intensifier from the lateral, the surgeon inserted the screw to the right of l1 while confirming that there were no problems with the trajectory or angle.After screws were inserted in all other planned positions, the cement was injected.While injecting the cement, the surgeon noticed that the cement was flowing from the dorsal side more than usual.After 1.0cc of the cement was inserted, the cement was flowing toward the dorsal side, so the surgeon stopped injecting any more cement and finished the injection.No problems were observed with cement injection in other positions, and the injection was completed smoothly.The surgery was completed successfully with no surgical delay.After surgery, ct scans showed that the cement had flowed into the pedicle.The amount of cement that flowed out is unknown.No cement leakage outside the vertebral body or pedicle was confirmed.No further information is available.This report involves one unk - biomaterial - cement: spine.This report is related to (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: d1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown biomaterial - cement: spine /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.E1: initial reporter facility name: yokohama rosai hospital, japan workers' health and safety organization e3: reporter is a j&j 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.

• Brand Name: UNK - BIOMATERIAL - CEMENT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: 18002887
• MDR Text Key: 326478317
• Report Number: 8030965-2023-13423
• 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
• Reporter Occupation: Other Health Care Professional

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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: 10/05/2023
• 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