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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNK - CONSTRUCTS: VIPER ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH UNK - CONSTRUCTS: VIPER ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown 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: jazini, e. Et al (2017), outcomes of lumbopelvic fixation in the treatment of complex sacral fractures using minimally invasive surgical techniques, the spine journal, vol. 17 (xx), pages 1238¿1246 (usa). The aim of this retrospective cohort study is to review our institution¿s experience with minimally invasive lpf as a supplemental stabilization method for the treatment of complex sacral fractures with and without unstable pelvic ring injuries. Between 2008 to 2014, a total of 24 patients (12 male and 12 female) with a mean age of 45±20. 4 years (range, 19-77 years) who underwent minimally invasive lumbopelvic fixation (lpf) were included in the study. Surgery was performed using viper instrumentation (depuy synthes spine, inc, raynham, ma, usa) combined with other competitor devices for associated pelvic ring injuries. The average follow-up duration for the entire cohort was 18. 8±16. 8 months (range, 0. 4¿64 months). The following complications were reported as follows: patient 11: a (b)(6) year-old male patient underwent revision instrumentation on postoperative day 3 for a malpositioned l5 pedicle screw seen on the postoperative computed tomographic scan. The screw was revised; however, the results of the neurologic examination were grossly unchanged at the time of discharge and the patient was still wearing an ankle-foot orthosis 1 year later. Patient 7: a (b)(6) year-old female patient presented 10 months later with pain at the lpf instrumentation site and had wound infection requiring antibiotic treatment and return to the or for irrigation and debridement with removal of instrumentation. Patient 12: a (b)(6) year-old male patient underwent serial irrigation and debridement procedures for his anterior and lateral wounds from traditional fixation beginning 4 days after undergoing minimally invasive lpf and subsequent removal of instrumentation on postoperative day 14 for persistent infections involving his pelvic wounds. Wound cultures grew vancomycin-resistant enterococcus and methicillin-resistant s. Aureus, which were treated with a combination of multiregimen antibiotics, including vancomycin, ciprofloxacin, ampicillin/sulbactam, meropenem, metronidazole, and trimethoprim/sulfamethoxazole. Patient 8: a (b)(6) year-old female patient who had morel-lavallée lesions over the sacrum, underwent removal of instrumentation (roi). Patient 3: a (b)(6) year-old male patient underwent elective removal of instrumentation. Patient 13: a (b)(6) year-old female patient underwent elective removal of instrumentation. Patient 19: a (b)(6) year-old female patient underwent elective removal of instrumentation. Patient 20: a (b)(6) year-old female patient underwent elective removal of instrumentation. Patient 22: a (b)(6) year-old female patient underwent elective removal of instrumentation. Patient 24: a (b)(6) year-old female patient underwent elective removal of instrumentation. Patient 15: a (b)(6) year-old male patient had returned on postoperative day 13 with a fever, altered mental status, and abdominal pain. The patient experienced a seizure and was subsequently intubated. Blood cultures were positive for escherichia coli, and cerebral spinal fluid cultures were negative. Computed tomography showed intra-abdominal free fluid and bowel wall thickening. The patient died as a result of high output cardiac failure, which resulted from sepsis on postoperative day 14, and this was not thought to be related to the minimally invasive lpf procedure. Of the 7 patients who underwent roi, only 1 had a fusion procedure. An unknown number of patients had an average estimated blood loss was 180±143 ml (range, 25¿500 ml). 16 patients required transfusions (2. 1±1. 3 units packed red blood cells; range, 0¿6 units). This report is for an unknown depuy spine viper mono/polyaxial screws. This is report 2 of 6 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: VIPER
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
SZ
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key12455116
MDR Text Key271004048
Report Number1526439-2021-01942
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/10/2021 Patient Sequence Number: 1
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