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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
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).

 
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Brand NameUNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL 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 Key12063909
MDR Text Key260500316
Report Number1526439-2021-01293
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeRS
Number of Events Reported1
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
Date FDA Received06/24/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/24/2021 Patient Sequence Number: 1
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