MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS-CRANIOFACIAL; PLATE,FIXATION,BONE

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

Patient Problems Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown constructs: plate/screws-craniofacial/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.(b)(4).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

Device report from synthes reports an event in finland as follows: this report is being filed after the review of the following journal article: salli m.I., nikunen m., and snäll j.(2022), primary reconstruction of extensive orbital fractures using two piece patient specific implants: the helsinki protocol, oral and maxillofacial surgery, vol.Xx (xx), pages 1-8 (finland).The aim of this single-centre retrospective study was to present the authors' experience of titanium-milled two-piece psis for primary reconstructions of eofmfs.In addition, they sought to evaluate their postoperative functional and aesthetic outcomes and postoperative complications compared to commercially available implants.Between january 2011 and october 2020, a total of 19 patients were included in the study.Of these, 5 patients (median age of 42 [range, 24-57] years) underwent reconstruction using two-piece psis which was designed preoperatively by one of the author and 14 patients (median age of 52 [range, 23-77] years) with commercial implants [10 patients had prebent orbital implants (matrix-orbital, depuysynthes) and 4 had unprebent orbital meshes (depuysynthes, matrixmidface)].The mean follow-up period for patients with two-piece psi and commercial implants was 99 (43¿160) days and 273 (24¿804) days, respectively.The following complications were reported as follows: 10 patients had suboptimal and 2 had poor implant position on the postoperative ct scan.Most of the suboptimal and poor positionings of the commercial implants were located in the posterior and medial parts of the fracture defect.13 patients had = 5 mm of the defect left uncovered.2 patients had 1¿4 mm of the defect left uncovered.8 patients had 5¿10 mm of the defect left uncovered.5 patients had > 10 mm of the defect left uncovered.2 patients had revision surgery.2 patients had significant globe malposition (> 2 mm).5 patients had any lower lid malposition.2 patients had lower lid malposition requiring surgical procedures.6 patients experienced any diplopia, which disturbed daily activities in 2, requiring evaluation at the strabismus policlinic in 1, and requiring prism glasses in 1.Patients with a poor implant position tended to have significant postoperative clinical symptoms; all of these patients had both significant gmp and some degree of diplopia (table 4).This report is for an unknown synthes craniofacial plate/screws constructs.A copy of the literature article is being submitted with this report.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS-CRANIOFACIAL
• 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: 14789829
• MDR Text Key: 295056476
• Report Number: 8030965-2022-04285
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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

• 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
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/23/2022
• 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