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 Problem Physical Asymmetry (4573)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; event occurred sometime in 2022.This report is for an unknown synthes mesh plates/unknown lot.Part and lot number 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: t.Matsuo, k.Yoshikawa, s.Oki et al.(2022), reconstruction surgery of intra-articular scapular fracture nonunion: a case report and literature review, jses reviews, reports, and techniques, volume 2, pages 68-74 (japan).This study presents a rare case of reconstruction surgery of ideberg type v intra-articular postoperative scapula fracture nonunion.This reports a case of a (b)(6)-year-old man fell from a 3-m-high ladder.He had a left ideberg type v scapular fracture and left proximal and distal clavicle fractures, showing the disruption of the superior shoulder suspensory complex with a floating shoulder.An open reduction and internal fixation procedure was performed, with a competitor¿s 2 cannulated cancellous screws and a distal clavicle plate.3 months postoperatively, he experienced minimal pain with daily activities and exhibited an elevation of 80 degrees.6 months postoperatively, he complained of a limited range of motion and persistent shoulder pain.Atrophy of the infraspinatus was observed.X-ray and computed tomography revealed union of the clavicle fracture; however, the glenoid fossa showed nonunion with inferior fragments which were internally rotated and anteriorly displaced.Magnetic resonance imaging suggested suprascapular nerve injury.A reconstruction surgery was performed for the scapular non-union.During the procedure, internal fixation of the scapula was performed using a competitor¿s 3.5mm cannulated cancellous screws inserted from the posterior inferior aspect of the glenoid fossa and an unknown synthes mesh plates on the osteotomy site and medial scapular body.However, the reconstruction surgery (first reconstruction surgery) was not successful, resulting in the postoperative malreduction of the glenoid fossa, because of which it was needed to repeat the surgery (second reconstruction surgery).Reoperation was performed 1 week later.Reduction was performed and fixation was conducted with a competitor¿s 2 3.5-mm cannulated cancellous screws inserted from the posterior inferior edge of the glenoid fossa and unknown synthes mesh plates on the glenoid neck, osteotomy site, and medial scapular body.The labrum, capsule, infraspinatus, and deltoid were all repaired.Postoperative computed tomography revealed good reduction and congruity of the glenoid fossa.1 year after the reconstruction, shoulder pain was almost absent during daily activities, and shoulder range of motion was 120 degrees elevation, 20 degrees external rotation, and l5 internal rotation.No shoulder instability or impingement was observed.Computed tomography revealed good reduction and osteosynthesis of the glenoid fossa.Magnetic resonance imaging showed repair of the infraspinatus tenotomy site.A slightly increased t2-weighted short tau inversion recovery signal intensity of the infraspinatus remained.This report is for the unknown synthes mesh plates.This is report 1 of 1 for (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14142774
• MDR Text Key: 289519429
• Report Number: 8030965-2022-02531
• Device Sequence Number: 1
• Product Code: HRS
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• 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: 03/22/2022
• 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: 68 YR
• Patient Sex: Male