MAUDE Adverse Event Report: SYNTHES GMBH TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH FOR 4.0MM RODS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	04.615.601S
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Unspecified Infection (1930); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
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.H11 additional narrative: b3 unknown event date e1: initial reporter is j&j company representative g4: device is not distributed in the united states, but is similar to device marketed in the usa.H4 device history part number: 04.615.601s lot number: 5692p97 manufacturing site: mezzovico release to warehouse date: 02 jun 2023 expiration date: 01 may 2033 a manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported an occipito-cervical fusion (occipital bone-t2) was performed on (b)(6) 2023.After the surgery, on (b)(6) 2024, the sales rep was informed the infection of the upper thoracic to cervical transition region.The second surgery was performed on (b)(6) 2024.In the revision surgery, the breakage of the plate in question was confirmed.Removal of the plate was considered, but was not removed by the surgeon's decision because it was not part of the original surgical planning.There was no instrumentation for removal of the plate, and there was a risk of instability from removal of the occipital plate.Patient outcome is stable.This report is for one ti occipital plate-medial 50mm width for 4.0mm rods this is report 1 of 2 for (b)(4).

• Brand Name: TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH FOR 4.0MM RODS
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MEZZOVICO; zona industriale 4; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19522246
• Report Number: 8030965-2024-07388
• Device Sequence Number: 8540927
• Product Code: KWP
• UDI-Device Identifier: 10705034740843
• UDI-Public: (01)10705034740843
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Expiration Date: 05/01/2023
• Device Catalogue Number: 04.615.601S
• Device Lot Number: 5692P97
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2023
• 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: UNK - SCREWS: OCCIPITAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown