MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: MATRIXMANDIBLE PLATES AND SCREWS; PLATE, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Date 12/22/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: tsuge, i.Et al (2022), central mandibular reconstruction by semiopen wedge osteotomy double-barrel fibula flap for a slim aesthetic appearance, plastic and reconstructive surgery - global open, vol.10 (e4716), pages 1-4 (japan).This study presents a case of a 78-year-old woman with a history of hypertension, hyperlipidemia, and diabetes, who noticed a mandibular gingival tumor from the right second incisor to right second premolar one month previously.Squamous cell carcinoma (ct4n0m0) was diagnosed after the examination of a biopsy specimen.Central mandibular resection from the area between the right second molar and left second premolar was planned by otolaryngologists.Although the patient was 78 years of age, she still had many maxillary teeth, and hoped for functionally and aesthetically high-quality reconstruction.The patient underwent four-segmented fibula osteotomy using a semiopen wedge technique characterized by a half-open wedge and half-closed wedge.The bone segments 1 and 2 were fixed with a prebent 2-mm-thick titanium reconstruction plate (matrix mandible angle reconstruction plate; johnson and johnson, nj, usa).Bone segments 3 and 4 were folded back with vascularization by peroneal vessels and successive periosteum, and fixed with 2.0-mm locking screws monocortically to 1-mm-thick titanium trauma plates (matrix mandible tension band plate; johnson and johnson).Postoperative ct showed no detached screws or broken plates (fig.3).In 2 years, a fistula from the right chin to the oral mucosa was found.All titanium plates were removed to prevent infection.Intraoperatively, we found excellent adhesion and remodeling of transferred bones (fig.4).The patient was satisfied with the aesthetic and functional outcomes.The height of the occlusal arch by the double-barrel matched to use a removable denture prosthesis stably.This report is for an unknown synthes 2-mm matrixmandible reconstruction plate/screws and unknown synthes 1-mm matrixmandible tension band plate/screws.This is report 2 of 2 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

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: d1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown construct: matrixmandible plates and screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: department of plastic and reconstructive surgery graduate school of medicine, (b)(6) university (b)(6) japan.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.

• Brand Name: UNK - CONSTRUCTS: MATRIXMANDIBLE PLATES AND SCREWS
• Type of Device: 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: 17949007
• MDR Text Key: 325831736
• Report Number: 8030965-2023-12984
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female