MAUDE Adverse Event Report: SYNTHES GMBH 1.8MM TI LOCKING SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	497.78
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthese reports an event in canada as follows: after a corpectomy completed on (b)(6) 2023, the implant became displaced and the superior portion of the construct slipped forward.This patient required a revision surgery completed on (b)(6) 2023 where new implants were used.The patient requires revision surgery or hardware removal.Hardware/explant removal due to: --implant expulsion through locking plate., patient had revision surgery on (b)(6) 2023 there was outcome/consequences.Patient had infection.There were other medical intervention; revision surgery, ct and x-rays.There is no information.This report is for one (1)1.8mm ti locking screw this is report 6 of 8 for complaint (b)(4).
Additional 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.Additional product codes: kwq and kwp, mhn 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: 1.8MM TI LOCKING SCREW
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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: 16470525
• Report Number: 8030965-2023-02574
• Device Sequence Number: 14735843
• Product Code: MNI
• UDI-Device Identifier: 10705034788340
• UDI-Public: (01)10705034788340
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 497.78
• Device Catalogue Number: 497.78
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/02/2023
• 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: 4.0MM TI CORTEX EXPHD SCR SLF-TAP 14MM; 4.0MM TI CORTEX EXPHD SCR SLF-TAP 14MM; 4.0MM TI CORTEX EXPHD SCR SLF-TAP 14MM; ECD-EXPANDABLECORPECTOMYDEVICE,HEIGHT30TO39MM,PEEK; TI CERV SPINE LOCKING PLATE 48MM (40MM)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female