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

Catalog Number UNK - BIOMATERIAL - CEMENT: SP

Device Problem Improper Chemical Reaction (2952)

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

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.This report is for an unk 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.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 synthese reports an event in japan as follows: it was reported that this was a posterior fusion and a percutaneous vertebroplasty (th12) for the 12th thoracic compression fracture on (b)(6) 2023.The event took place in sequence as follows: 1.The expedium verse fenestrated screws were inserted into th10, th11, l1, and l2.Then, cement augmentation was performed.2.After cement augmentation, a bkp was performed with synflate at th12.Both side of balloons were inflated up to 4.0 ml.3.7 cc of the cement was injected on th12 right, and 3.8 cc of the cement was injected on th12 left.At the end of cement injection, 12 minutes have elapsed since the start of cement mixing.3.The cement needle and the sleeve were removed.The guide wire was injected, and then the screws were immediately injected without tap.Although the screws were inserted on both sides, right side of the guide wire could not be removed because of cement hardening.At this point, 15 minutes and 30 seconds have elapsed since the start of cement mixing.4.The screw was removed because the guide wire could not be removed.The guide wire was cut by the pin cutter.Approximately 3 to 4 cm of the guide wire remained at root of the vertebral column.The surgeon intended to limit the insertion to the root of the vertebral arch or the posterior wall of the vertebral body because of the risk of guide wire becoming stuck due to cement hardening.However, the rate of cement hardening was greater than the surgeon expected.The surgeon commented that there was no problem with the devices, and that it was a procedural problem.The surgeon thinks that the cause was the insertion of the guide wire.Considering the rate of cement hardening, the surgeon commented that in the future, the surgeon will not use guide wire or tap for screw insertion during bkp with cement augmentation.The surgeon will insert screws directly.There was 30 minutes surgical delay.The procedure was successfully completed.Patient outcome/status is stable.*remarks: (b)(4) and (b)(4) are involved with the same event.(b)(4) (synthese spine): cement (b)(4) (depuy spine): guide wire no further information is available.Unk - guide/compression/k-wires: viper (part# unknown; lot# unknown; quantity: unknown) unk - screws: spine-us (part# unknown; lot# unknown; quantity: unknown) unk - cutting instruments: spine (part# unknown; lot# unknown; quantity: unknown) unk - synflate/vbs (part# unknown; lot# unknown; quantity: unknown) 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: 16484786
• MDR Text Key: 311381018
• Report Number: 8030965-2023-02661
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - BIOMATERIAL - CEMENT: SP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• 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
• Treatment: UNK - CUTTING INSTRUMENTS: SPINE; UNK - GUIDE/COMPRESSION/K-WIRES: VIPER; UNK - SCREWS: SPINE-US; UNK - SYNFLATE/VBS
• Patient Sex: Female