MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMEDF ORBITAL RIM PL/12 H/0.5; PLATE, BONE

Catalog Number	04.503.343
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Loss of Vision (2139)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).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: d4: additional pro-code: dzl.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 or Problem Description
It was reported that on (b)(6) 2024, after a facial fracture case, the surgeon learned that the patient was having vision issues.The pre-op and post-op vision were intact.During surgery, synpor was placed to treat the orbital floor fx.An orbital rim titanium plate was also placed.Ct imaging was done post op.Late at night, the patient was brought back to the or to remove orbital floor plate with concern of a hematoma.Surgeon reported on 3/19 that the patient has lost vision.There was adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing.It is unknown if the procedure was completed successfully or if there were patient consequences.This report is for one (1) ti matrixmedf orbital rim pl/12 h/0.5 this is report 1 of 3 for complaint (b)(4).

• Brand Name: TI MATRIXMEDF ORBITAL RIM PL/12 H/0.5
• Common Device Name: PLATE, BONE
• 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: 19041655
• Report Number: 8030965-2024-04493
• Device Sequence Number: 8548838
• Product Code: JEY
• UDI-Device Identifier: 10887587019918
• UDI-Public: (01)10887587019918
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.503.343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/04/2024
• 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: SYNPOR SMO TI RNFRC FN PL FIXTN H/0.8-S; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female