MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; APPLIANCE, FIXATION, NAIL

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

Patient Problems Pulmonary Embolism (1498); Bone Fracture(s) (1870); Osteolysis (2377); No Code Available (3191)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: this report is for an unknown screw/rod construct accessories/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: ghobrial, g.M.Et al (2017), prophylactic vertebral cement augmentation at the uppermost instrumented vertebra and rostral adjacent vertebra for the prevention of proximal junctional kyphosis and failure following long-segment fusion for adult spinal deformity, the spine journal, vol.17 (10), pages 1499-1505, https://www.Thespinejournalonline.Com/article/s1529-9430(17)30207-3/abstract (usa).The aim of this retrospective cohort-matched surgical case series study is to assess the incidence of pjk and pjf in patients treated with prophylactic polymethylmethacrylate (pmma) cement augmentation at the uppermost instrumented vertebrae (uiv) and rostral adjacent vertebrae (uiv+1).Between july 20, 2000 to july 26, 2016, a total of 85 patients (37 male and 48 female) with a mean age of 64 years (sd=±11.1) underwent a long-segment posterior fusion.Surgery was performed using a cement augmentation system (confidence spinal system, depuy synthes spine, raynham, ma, usa) in 38 patients at the uiv and uiv+1 (group b).Group a consisted of 47 control patients without cement augmentation using expedium pedicle screws.The mean follow-up duration was 27.9 and 24.2 months in groups a and b, respectively.The following complications were reported as follows: 9 patients in group b had proximal junctional kyphosis.4 patients had major complications, all of which were pulmonary embolisms encountered in the postoperative inpatient period requiring anticoagulation in 3 (4%) and inferior vena cava filter in 1 patient followed by anticoagulation.6 had durotomies which were repaired primarily at the time of surgery and did not require future surgical management.6 patients had pseudoarthrosis (7%), equally divided between the osteotomy site (n=3) and at the l5¿s1 level (n=3).6 patients in group a developed proximal junctional failure (pjf) requiring proximal extension of fusion.This report is for an unknown depuy spine cement and unknown depuy spine screw/rod constructs.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown screw/rod construct accessories.This is report 2 of 2 for pc (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: APPLIANCE, FIXATION, NAIL
• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10602976
• MDR Text Key: 209136007
• Report Number: 1526439-2020-01827
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2020
• 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