MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; SCREW,FIXATION,BONE

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Dysphagia/ Odynophagia (1815); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patient involved.Implantation date unknown.This report is for an unknown screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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.(b)(4).

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: chen y, et al.(2020), comparison of anterior controllable ante displacement and fusion (acaf) with posterior laminoplasty in the treatment of multilevel cervical ossification of the posterior longitudinal ligament: a prospective, randomized and control study with at least one-year follow-up, spine an international journal for the study of the spine, page 1-21, (china) this study aims to compare anterior controllable ant displacement and fusion (acaf) with laminoplasty in the treatment of multilevel ossification of the posterior longitudinal ligament (opll) and evaluate the efficacy and safety of this procedure.Between september 2016 and april 2018, 80 patients with multilevel ossification of the posterior longitudinal ligament (opll) were included in the study.These patients were randomized in a 1:1 ratio to anterior controllable ante displacement and fusion group (acaf) and laminoplasty group.In the acaf group, there were 40 patients (23 males and 16 females) with a mean age of 54.6+/-11.2 years.These patients underwent fixation using an unknown depuy spine skyline anterior cervical plate system with peek cage.After surgery, all patients were immobilized in a philadelphia collar for 6-8 weeks.Meanwhile, in the laminotomy group, there were 40 patients (20 males and 18 females) with a mean age of 57.2 +/-10.4 years.These patients underwent fixation using a synthes arch miniplate fixation system.After surgery, all patients were immobilized in a philadelphia collar for 3-4 weeks.The outpatient follow-up was routinely carried out at the time of 3, 6, and 12 months postoperatively, and the final visit was set as 12 months postoperatively.The overall follow-up period of the patients ranged from 12 to 30 months (average 18.6 +/- 4.5months).Complications were reported as follows: 2 patients had cerebrospinal fluid leakage.1 patient had c5 palsy.2 patients had axial pain.6 patients had dysphagia.4 patients had hoarseness.This report is for an unknown depuy spine skyline anterior cervical plate system with peek cage a copy of the literature article is being submitted with this medwatch.This complaint involves three (3) devices.This is report 2 of 3 (b)(4).Related product complaint: (b)(4).

• Brand Name: UNKNOWN SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10448225
• MDR Text Key: 208003855
• Report Number: 1526439-2020-01517
• Device Sequence Number: 1
• Product Code: HWC
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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: 07/30/2020
• 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