MAUDE Adverse Event Report: DEPUY SPINE INC 4.0 PLY SCRW 4.5X10; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 1020-45-110S

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

Patient Problem Bone Fracture(s) (1870)

Event Date 05/13/2022

Event Type  Injury  

Event Description

Device report from japan reports an event as follows: it was reported that during a posterior fusion (c5-6) for treating cervical injury on (b)(6) 2022, while a screw was being inserted at c5, the bone broke.The surgeon abandoned the attempt to deploy a screw on the right lesion.Only a fusion on the left side was accomplished.The procedure was completed without delay.Patient was stable.This report is for a 4.0 ply scrw 4.5x10.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.Additional narrative: additional procode: kwp.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.

• Brand Name: 4.0 PLY SCRW 4.5X10
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14649632
• MDR Text Key: 294853661
• Report Number: 1526439-2022-00821
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034521879
• UDI-Public: (01)10705034521879
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192014
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1020-45-110S
• Device Catalogue Number: 102045110S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/09/2022
• 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
• Patient Outcome(s): Required Intervention