MAUDE Adverse Event Report: DEPUY SPINE INC MIS TI CFX FEN POLY 6X50; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Catalog Number	186727650
Medical Device Problem Codes	Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Metal Related Pathology (4530)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in austria as follows: it was reported on (b)(6) 2023, of a questionable metalosis of a cfx screw that has to be removed.The screws have been removed because it turned out that they were loose.Initially, the surgery was necessary to extend the construct due to degeneration at the adjacent level.During the removal of the screw, it seemed like there could be metalosis.The customer wanted us to investigate if metalosis was evident or could be excluded.There was no surgical delay.The procedure was successfully completed.No fragments were generated.There were no patient outcomes or consequences.This report is for one (1) (b)(4).This is report 1 of 2 for complaint mis ti cfx fen poly 6x50.
Additional 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: d2b: additional product code: mni.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 or Problem Description
This complaint involves one mis ti cfx fen poly 6x50.This is report 1 of 2 for (b)(4).

• Brand Name: MIS TI CFX FEN POLY 6X50
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• 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: 17799013
• Report Number: 1526439-2023-01788
• Device Sequence Number: 15266379
• Product Code: PML
• UDI-Device Identifier: 10705034282572
• UDI-Public: (01)10705034282572
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 186727650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SINGLE-INNER SETSCREW.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female