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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNK - CONSTRUCTS: VIPER 2 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH UNK - CONSTRUCTS: VIPER 2 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: 510k: 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: moser m. , jost j. , and nevzati e. (2021), kyphoplasty versus percutaneous posterior instrumentation for osteoporotic vertebral fractures with posterior wall injury: a propensity score matched cohort study, journal of spine surgery, vol. 7 (1), pages 68-82 (switzerland). The aim of this retrospective, propensity score-matched cohort study is to evaluate our center¿s procedural data, surgical results, and perioperative complications in a cohort of patients with ovfs with posterior wall injury who underwent treatment with bkp with or without percutaneous posterior instrumentation. Between january 2010 to december 2018, a total of 50 patients (7 male and 43 female) with a mean age of 74. 4±9. 5 years, who underwent balloon kyphoplasty with or without percutaneous posterior instrumentation with pedicle screws, were included in the study. These patients were divided into 2 groups based on surgical treatment received. Percutaneous instrumentation was performed using viper® 2 (depuy synthes spine, oberdorf, switzerland) until 2015, and a competitor from 2016 to 2018. Bkp was performed using confidence spinal cement system® (depuy synthes spine, oberdorf, switzerland) and a competitor device. The average follow-up was 8. 4 months (range, 1¿56. 4 months). The following complications were reported as follows: bkp group: 6 patients developed a complication within 30 days after surgery, 4 of which required drug treatment due to urinary tract infection (n
=
1), hypokalemia (n
=
1), hypertensive crisis (n
=
1), and hypertensive crisis, hyperkalemia, and hyponatremia (n
=
1). 1 patient had moderate complication (complicated urinary tract infection requiring suprapubic catheter) and 1 had a severe complication (acute pericarditis). 13 patients had opioid use at discharge. 2 patients were readmitted within 30-day. 3 patients had opioid use at 3-month follow-up. 11 patients had subsequent fractures within 3-month follow-up. 4 patients showed fracture progression of the cement augmented level, which was managed conservatively in all cases. An unknown number of patients had an average loss of correction of 3. 8° in the sagittal cobb angle, 2. 8° in the vertebral wedge angle, and 2. 2 mm in the anterior vertebral height. 7 patients had cement leakage. Of these, 2 occurred intraspinally which was asymptomatic, and 5 ventrally or laterally confined to vertebral level. Ps group: 11 patients developed a complication within 30 days after surgery, 10 of which required drug treatment due to urinary tract infection (n
=
2), anemia requiring transfusion of red bloods cells (n
=
1), delirium (n
=
1), fluid overload and hyponatremia (n
=
1), pulmonary cement embolism (dyspnea) requiring anticoagulation, hyponatremia, hypokalemia, anemia requiring transfusion of red blood cells, urinary tract infection (n
=
1), pulmonary embolism (n
=
1), pulmonary embolism, delirium, pneumonia (n
=
1), urinary tract infection, hypokalemia (n
=
1), transient proximal muscle weakness in the right leg and subsequent fracture of lower instrumented vertebra (l4) (n
=
1). 1 patient had moderate complication (obstructive micturation requiring suprapubic catheter). 21 patients had opioid use at discharge. 1 patient was readmitted within 30-day. 4 patients had opioid use at 3-month follow-up. 9 patients had subsequent fractures within 3-month follow-up. 2 of these patients who received instrumentation two levels above and one level below the index level: one was managed conservatively, and another underwent revision surgery with caudal extension of the instrumentation 83 days after the index procedure. An unknown number of patients had an average loss of correction of 1. 6° in the vertebral wedge angle, and 2. 3 mm in the anterior vertebral height. 11 patients had cement leakage. Of these, 9 occurred ventrally or laterally confined to vertebral level, 1 ventrally or laterally >1 level, and 1 occurred at the adjacent level. This report is for an unknown depuy spine viper 2 constructs and unknown depuy spine confidence cement. A copy of the literature article is being submitted with this medwatch.
 
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Brand NameUNK - CONSTRUCTS: VIPER 2
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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 Key12468545
MDR Text Key271345299
Report Number1526439-2021-02000
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
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 Received12/30/2021
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: 09/14/2021 Patient Sequence Number: 1
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