MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problems Hematoma (1884); Pain (1994); Impaired Healing (2378); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown expedium spine system/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: krutko av (2012), results of decompression and stabilization surgeries via a unilateral approach in lumbar spinal stenosis, neurosurgery issues, volume 2, (russia).The objective of the study was to investigate the capabilities, advantages and limitations of bilateral decompression via a unilateral approach in decompression and stabilization interventions in patients with lumbar spine degeneration and develop the technology and techniques to perform it.The study included 372 patients (age range was 27-74 years).All of them were operated due to clinical manifestation of lumbar spinal stenosis.The patients were divided into 2 groups- the main group and the comparison group.The main group consisted of 44 patients who underwent surgery from january 2010 to august 2011 with decompression and stabilization surgery performed at one or more vertebral levels as bilateral decompression via a unilateral approach, transpedicular fixation and posterior interbody fusion with cages.The main group had 20 men and 24 women aged 42 to 74 years (at the mean 56.24+/-10.4 years) the comparison group consisted of 328 patients who underwent surgery from january 2008 to august 2011.They underwent decompression and stabilization intervention via a traditional posteromedial approach.To decompress the intracanal neurovascular masses, a laminectomy or bilateral interlaminectomy with partial or full facetectomy was performed on both sides.The surgery was completed with transpedicular fixation and interbody fusion.The comparison group had 148 men and 180 women aged 27 to 72 years (at the mean 50.28+/-18.2).Constructs and instruments used for transpedicular fixation included the unknown depuy spine expedium spine system and competitors¿ devices.For interbody fusion, the unknown depuy concorde niti foam implants and competitors¿ devices were used.The article did not specify which patients were implanted with the depuy spine devices.Thus, complications will be reported as follows: main group: 1 patient had medial malposition of 1 screw which did not cause clinical symptoms nor require surgical correction.1 patient had lateral malposition of screw which did not cause clinical symptoms nor require surgical correction.2 patients had dural sac injury intraoperatively during the microsurgical decompression, which in 1 case was associated with spinal root injury as well.In those cases, the dural sac was hermetically sutured.3 patients had no change in pain syndrome overtime.Comparison group: 13 patients had postoperative wound complications which required excision of necrotizing edges and secondary sutures.11 patients had an intramuscular lysed hematoma formed in the postoperative period.3 patients had early deep infection of the postoperative wound.2 patients had late deep infection that required revision of the surgical intervention area and installation of drain tubes.1 patient had a removal of transpedicular construct due to infection, but the interbody construct remained, enabling the patient to live an active lifestyle.In the 2 patients who had infections, the construct remained fully intact.12 patients had malposition of 12 screws; 2 cases required repeat surgical treatment to correct the position of the construct.9 patients had injury to the dura mater, and it was hermetically sutured.However, in 1 case a cerebrospinal fluid pad formed in the lumbar region, manifesting as liquor-dynamic orthostatic impairments, which required duraplasty.This report is for the unknown depuy spine expedium spine system.It captures the reported events of intraoperative dural sac injury, spinal root injury, no change in pain syndrome, postoperative wound complication, intramuscular lysed hematoma, infection, injury to dura mater, and csf pad formed in the lumbar region.This is report 1 of 3 for (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• 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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12079558
• MDR Text Key: 266298760
• Report Number: 1526439-2021-01331
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2021
• 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