MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unk mono/polyaxial screws/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.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: wang, m.Y.Et al (2010), an analysis of the differences in the acute hospitalization charges following minimally invasive versus open posterior lumbar interbody fusion, journal of neurosurgery: spine, vol 12 (xx), pages 694¿699 (usa).The aim of this retrospective study is to review the author's experiences with hospitalization costs at an academic medical center.During a 14-month period, a total of 74 patients (mean age 55 years) were included in the study.The series included 59 single-level operations (75% mis and 25% open), and 15 2-level surgeries (53% mis and 47% open).The open procedure was performed using polyaxial titanium expedium transpedicular screws (depuy spine, inc.) and for mis, viper pedicle screw (depuy spine, inc.) was used.All operations included bilateral transpedicular screw-rod fixation.The mean follow-up period was unknown.The following complications were reported as follows: open group: 6.7% and 14.2% of the patient in the single-level and 2-level surgeries had dural tears.6.7% of the patient in the single-level had neurological deficit.14.2% in the 2-level had pulmonary complications.28.6% of the patients in the 2-level had cardiac complications.14.2% of the patients in the 2-level had wound infection.Mis group: 4.5% of the patients in the single-level had neurological deficit.12.5% of the patients in the 2-level had cardiac complications.12.5% of the patients in the 2-level had dural tears.This report is for an unknown depuy spine expedium constructs and unknown depuy spine viper constructs.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk mono/polyaxial screws.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12442048
• MDR Text Key: 270407241
• Report Number: 1526439-2021-01888
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention