MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE OBL L-PL 3X4 H-LT/0.7; PLATE, BONE

Catalog Number	04.503.355
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
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 d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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) 2020 the patient underwent nasal reconstructive surgery.One synthes, l-shape and one synthes, straight 0.5mm, multi-hole titanium mini plates were used in her surgery.One of the mini-plates was screw fixated to the right nasal bone with the mini-plate extending subcutaneously to the right external nasal valve/nostril, for support of the right internal and external valves.The other mini-plate was suture-secured to the cartilaginous dorsal and caudal nasal septum, submucosally, for support of the nasal dorsum and tip.The patient did well postoperatively until approximately (b)(6) 2020, when excessive mobility of the right side mini-plate at the screw fixation sites on the right nasal bone was discovered.Revision surgery with re-fixation of the right side mini-plate to the nasal bone was performed on (b)(6) 2021.The patient did well with normal, comfortable breathing until (b)(6) 2024, when the right-side nasal obstruction recurred due to valve collapse.The patient subsequently underwent dental x-rays for a separate issue that revealed mini-plate discontinuities.Detailed x-rays of the nasal bones were obtained on (b)(6) 2024, showing complete discontinuity of the mid regions of both of the mini-plates.The cause of the mini-plate discontinuities is unknown, but it cannot be explained by nasal trauma or other similar factors, as there has been no such trauma sustained by the patient since the time of her initial surgery in 2020.The patient will require revision nasal surgery for replacement of the mini-plates, as her right-side nasal breathing is significantly obstructed due to recurrent nasal valve collapse secondary to the mini-plate discontinuity resulting in failure of rigid support of the right nasal valve.
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: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: TI MATRIXMIDFACE OBL L-PL 3X4 H-LT/0.7
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20439695
• Report Number: 8030965-2024-12781
• Device Sequence Number: 18140308
• Product Code: JEY
• UDI-Device Identifier: 10887587020037
• UDI-Public: (01)10887587020037
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.503.355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI MATRIXMIDFACE ADAPTION PL/20 H/0.5; TI MATRIXMIDFACE EMERGENCY SCREW 4MM; TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female