MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/rod construct accessories/unknown lot.Part and lot number 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

This report is being filed after the review of the following journal article: goertz l., et al (2020) impact of obesity on complication rates, clinical outcomes, and quality of life after minimally invasive transforaminal lumbar interbody fusion, journal of neurological surgery part- a volume 82, pages 147¿153 (germany).This retrospective, observational, single-center study aims to compare surgical complications, long-term pain outcome, and hrqol between obese and nonobese patients who underwent mistlif for degenerative spine disease.Between 2011 and 2014, 71 patients (50 females,21 males) age 64.6-10.8 years underwent mis-tlif at a high volume tertiary care hospital.All patients were treated by the mis-tlif technique using polyaxial pedicle screws (viper 2 system, depuy synthes, raynham, massachusetts, united).The target disk was removed, and a peek cage (tpal, depuy synthes) filled with autologous bone chips was placed in the anterior third of the intervertebral space under fluoroscopic guidance.Follow-up duration (mo) 53.4 -12.8.The following complications were reported: 9 dural tears.1wound infection.1 rebleeding.Patients with postoperative neurological deficits (1 with a motor deficit, 1 with a sensory deficit, and 2 patients with a motor-sensory deficit).13 revision surgery.Screw avulsion or breakage in 5 patients.Cage migration and screw avulsion or breakage in 2 patients.Screw accuracy: n=10) grade 2, <2mm threads outside the pedicle.N=5) grade 3: 2 to 4mm of core screw diameter outside the pedicle.This report is for an unknown depuy spine polyaxial pedicle screws (viper 2 system).This is report 1 of 4 for (b)(4).Additional reports are captured under (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 12313073
• MDR Text Key: 266225161
• Report Number: 1526439-2021-01669
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/13/2021

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: 07/13/2021
• Initial Date FDA Received: 08/12/2021
• 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