MAUDE Adverse Event Report: SYNTHES GMBH TI 12-POINT NUT-11MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 499.294

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/14/2023

Event Type  Injury  

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.H10 additional narrative: d2: additional procodes: kwp, kwq, mnh, mni.D9: complainant part is not expected to be returned for manufacturer review/investigation.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 australia reports an event as follows: it was reported that on december 14, 2023, the surgeon removed two in-situ screws, green nut, and polyaxial head constructs bilaterally from a single level during this procedure (these were in-situ from patient's previous fusion).The surgeon then placed screws bilaterally in the adjacent level, and re-used the screw head and green nut from one of these constructs on one of the new screws he had placed.No screws were re-used.The revision surgery was due to further degeneration of the patient¿s spine, and not related to products in situ.There have been no known complications post-operatively, and no known issues with prosthetics prior to removal of single level screws.This report is for a ti 12-point nut-11mm.This is report 1 of 4 for (b)(4).

• Brand Name: TI 12-POINT NUT-11MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18484923
• MDR Text Key: 332563348
• Report Number: 8030965-2024-00563
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819728011
• UDI-Public: (01)07611819728011
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082572
• 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: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 499.294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• 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 - SCREWS: SPINE-US; UNK - SCREWS: SPINE-US; USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE
• Patient Outcome(s): Required Intervention