MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: SPINE; PLATE,FIXATION,BONE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plates: spine /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.(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 (b)(6) as follows: this report is being filed after the review of the following journal article: wei, f.Et al (2020), a prospective randomized cohort study on 3d-printed artificial vertebral body in single-level anterior cervical corpectomy for cervical spondylotic myelopathy, annals of translational medicine, vol.8 (17), pages 1¿9 (china).The aim of this prospective randomized open-label cohort study is to investigate the in vivo safety and efficacy of ebm-avb in comparison to tmc used in patients undergoing single-level accf (sl-accf) for csm.Between january 2016 to september 2016, a total of 40 patients were included in the study.There were 20 patients (14 male and 6 female) in the ebm-avb group (55.2±11.4 years; range, 31¿76 years) and 20 patients (11 male and 9 female) in the tmc group (53.8±7.8 years; range, 37¿64 years).Surgery was performed using a semi-constrained cervical plate (cslp, depuy-synthes, us).All patients in both groups had complete clinical and radiographic follow-up data 6 months following the surgery.The mean follow-up was unknown.The following complications were reported as follows: 1 patient in the tmc group, who had no fusion at 6-month postoperative, showed signs of screw loosening.However, the patient was asymptomatic and surgical revision was saved for a prolonged course of immobilization with a philadelphia collar.Implant subsidence was statistically more significant in the tmc group than in the ebm-avb group at the 6-month follow-up (mean loss of height 2.39±1.68 vs.1.39±1.05 mm, p=0.015) (table 2).1 out of 20 patients in the ebm-avb group had severe subsidence.7 out of 20 patients in the tmc group had severe subsidence.This report is for an unknown synthes spine plates.A copy of the literature article is being submitted with this medwatch.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - PLATES: SPINE
• 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: 11029175
• MDR Text Key: 222093853
• Report Number: 8030965-2020-09840
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention