MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TITANIUM MESH IMPLANT; PLATE,FIXATION,BONE

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Visual Disturbances (2140); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates: titanium mesh implant/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Event Description

This report is being filed after the review of the following journal article: zeller., et al (2020) self-centering second-generation patient-specific functionalized implants for deep orbital reconstruction, j stomatol oral maxillofac surg xxx (xxxx) xxx¿xxx (germany).This study aims to clarify whether the novel method for analyzing the orbital implant fit could be used as an additional tool for intraoperative quality control and for transferring the virtual plan more precisely into the patient.Between 2014 and 2020, the department´s database was screened for patients who were treated with an additively manufactured, second-generation patient-specific titanium orbital implant with self-centering design features (stabilizers).In total, 31 patients were eligible and could be included in the study group (self-centering design).Patients who had received cad-based individualized titanium orbital implants without a self-centering design were assigned to the control group (n=50).Of those 50 patients, 7 implants were excluded according to the exclusion criteria.Finally, 42 implants met the criteria and were subjected to the implant fit analysis (ifa).Implants assigned to the control group shared the following characteristics: cad-based individual titanium orbital implants, orbital fan mesh plates (depuy synthes, switzerland) that were pre-formed and -bent on a 3d-printed bio model of the patient based on mirroring.Implants assigned to the study group shared the following characteristics: additively manufactured titanium implants, preventive design (¿¿inverted snow shovel design¿¿, and a circular, rounded implant border), and functionalization features including measurements and tracks for intraoperative navigation and insertion.Transconjunctival approaches without lateral canthotomy or transcaruncular extension were used for all cases.After insertion and correct placement, all implants were secured with 1 single titanium screw with either a 1.1 mm (kls martin, tuttlingen germany), 1.3 mm (depuy synthes, compact system), or 1.55 mm (matrix midface, depuy synthes) in diameter, depending on surgeon¿s preference or the manufacturer's specifications.As a part of the local, standardized follow-up scheme, patients were examined at 1, 4, and 12 ( 2) weeks.The following complications were reported as follows: revision surgery for repositioning was needed in only one case.Even though the implant position was exactly as planned, one case needed revision surgery due to a transient postoperative partial palsy of the inferior rectus muscle.During revision surgery, no entrapment of the muscle was found and the implant position was not changed.Without further measures being taken, the partial palsy disappeared after ten days.Intraorbital hematoma.Severe bleeding.Deep wound infections.At 12 weeks, 33 of 42 patients with cad-based-individualized implants could be followed up.Two patients showed a motility disturbance and 7 still had diplopia 12 weeks ( 2 weeks) after surgery.In the study group, 18 patients attended the 12 weeks follow-up, and 3 were lost to follow-up.Three patients suffered from double vision and 1 of them showed motility disturbance.Implant fit analysis revealed a significantly more precise (p < 0.001) positioning in the study group (n = 22/31) than in the control group (n = 42/50).This report is for an unknown synthes individual titanium orbital implants, orbital fan mesh plates, 1.3 mm (depuy synthes, compact system), or 1.55 mm (matrix midface).

• Brand Name: UNK - PLATES: TITANIUM MESH IMPLANT
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12354179
• MDR Text Key: 267682954
• Report Number: 8030965-2021-07068
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• 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: 07/26/2021
• 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