MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Nerve Damage (1979); Pain (1994); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown viper construct/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: akhmetyanov s.A., krutko a.V.,(2011) results of surgical treatment of degenerative lesions of the lumbrosacral spine, universal decimal classification (udc) 616.711-089, pages 1-10 (russia).This study aims to compare the clinical effectiveness of standard open decompressive-stabilizing surgical interventions performed from posteromedial access and the minimally invasive surgical treatment of a degenerative-dystrophic lesion of the lumbosacral spine in similar groups of patients.Over the period extending from 2009 through 2011, 147 patients who underwent surgery at the neurovertebrology clinic of the novosibirsk research institute of traumatic surgery and orthopedics (ritso) satisfied the inclusion criteria.The patients were divided into two groups via the random sampling technique using a computer program.64 patients in the minimally invasive intervention group and 68 patients in the traditional open technique group went through the full study.In the treatment group (group i), 64 patients underwent surgery, 31 of whom were men and 33 of whom were women, ranging from 23 to 70 years of age (= 50.04 ± 11.63).In the comparison group (group ii), 68 patients underwent surgery, 35 of whom were men and 33 of whom were women, ranging from 23 to 70 years of age (= 50.05 ± 11.69).In the patient treatment group (group i), minimally invasive surgical techniques were used to treat vertebrogenic pain syndromes.Pedicular screws were inserted.In the comparison group (group ii), all the decompressive-stabilizing interventions were performed from traditional posteromedial access with the skeletization of the posterior parts of the spinal column.A similar amount of stabilization was performed on these patients, together with the adequate traditional decompression of the intracanal neurovascular structures (a decompressive laminectomy).Transpedicular fixation was accomplished using legacy, expedium, viper, sextant, and longitude structures and instruments.Interfix, capestoune, and concorde porous implants made from ni-ti, aesculape instruments, and quadrant and pipeline tubular retractors were used for interbody fusion.Within 3 months after surgical intervention, all the patients underwent an x-ray examination.Within 12¿24 months after surgery, an msct examination of the spine was performed.The clinical results of the surgical treatment performed were studied 3-6 months later in 147 patients and 12-24 months later in 132 patients.The following complications were reported as follows: group i: 2 damage to the dura mater.1 augmentation of paresis or hypesthesia in the root innervation area.1 myeloradiculoischemia.Unsatisfactory results came to in group i (2 patients).Where unsatisfactory result is the absence of an effect from surgery, deterioration, and a pain syndrome relapse.One patient in group i developed radiculomyeloischemia at the conus-epiconus level: lower flaccid paraplegia accompanied by pelvic organ dysfunction.Group ii: 2 damage to the dura mater.2 myeloradiculoischemia.3 suture sinus.2 augmentation of paresis or hypesthesia in the root innervation area.7 partial postoperative wound edge breakdown.2 deep infection of the surgical intervention area.Unsatisfactory results came to in group ii (2 patients).Where unsatisfactory result is the absence of an effect from surgery, deterioration, and a pain syndrome relapse.Violation of pedicular screw integrity was noted in two cases in the minimally invasive intervention group, which required a second surgical intervention: the remounting of the transpedicular structure on one side.Two patients in both groups, the transpedicular structure was remounted when the pedicular screw broke.This report is for an unknown depuy spine viper construct.This is report 2 of 5 for (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 12063909
• MDR Text Key: 260500316
• Report Number: 1526439-2021-01293
• Device Sequence Number: 1
• Product Code: NKB
• 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: 06/03/2021

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: 06/03/2021
• Initial Date FDA Received: 06/24/2021
• 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