UNKNOWN MONO/POLYAXIAL SCREWS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-11 for UNKNOWN MONO/POLYAXIAL SCREWS manufactured by Medos International Sàrl Ch.

Event Text Entries

[184172455] If the information is unknown, not available or does not apply, the section/field of the form is left blank. There are multiple patients all information is provided in the article. 510k: this report is for an unknown mono/polyaxial screw/unknown lot. Part and lot number are unknown; udi number is unknown. Implant date is between (b)(6) 2015 to (b)(6) 2017. 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.
Patient Sequence No: 1, Text Type: N, H10


[184172456] This report is being filed after the review of the following journal article: konieczny m. , krauspe r. , (2019) navigation versus fluoroscopy in multilevel mis pedicle screw insertion, clinical spine surgery , volume 32 (5), number 5, pages e258? E265,(germany) doi: 10. 1097/bsd. 0000000000000807. This retrospective study aims to analyze the impact of navigation on mis in multilevel fixations with a separate investigation of a dose of radiation for patient and surgeon, the accuracy of screw placement, and whether navigation in mis leads to a higher rate of approach-related complications due to placement of reference in patients with malignant neoplastic disease. From october 2015 to december 2017, 22 patients who were treated by mis multilevel spondylodesis by a pedicle screw rod construct to stabilize an mls were included in the study. 205 screws were enrolled in the analysis. These patients were divided into two groups: fluoroscopy group with 10 patients age 58. 3 (3. 7)) and navigation group with 12 patients age 58. 3 (3. 7). The mis pedicle screw rod? System viper (depuy synthes, germany) was used in all patients. One-hundred eighteen screws (12 patients) have been inserted guided by navigation (pin) and 87 screws (10 patients) guided by fluoroscopy (pif). Follow-up for all patients was set at a minimum of 3 months. The following complications were reported as follows: pif (fluoroscopy group): 1 screw was classified as type ii / grade 2, 2? 4mm of core screw diameter outside pedicle, according to upendra. 1 screw was classified as type iii / grade 3, entire screw outside the pedicle, according to upendra. A revision was offered to the patient in whom the screw was placed outside the pedicle by full diameter. The patient refused revision surgery (presently 16 mo postoperative). Pin ( navigation group): 2 screw was classified as type ii / grade 2, 2? 4mm of core screw diameter outside pedicle, according to upendra. One patient ((b)(6) y, bmi: 37) developed pleural effusions 1 week after the operative procedure and was treated conservatively. 1 patient ((b)(6) y, bmi: 28) developed a pulmonary embolism 4 weeks after the operative procedure during chemotherapy of her breast cancer. This report is for an unknown depuy spine mis pedicle screw rod? System viper. A copy of the literature article is being submitted with this medwatch. This report is for one unknown mono/polyaxial screws. This is report 3 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1526439-2020-00694
MDR Report Key9820004
Report SourceFOREIGN,LITERATURE
Date Received2020-03-11
Date of Report2020-02-14
Date Mfgr Received2020-02-14
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetCHEMIN-BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal02400
Manufacturer Phone6103142063
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN MONO/POLYAXIAL SCREWS
Generic NameORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
Product CodeMNH
Date Received2020-03-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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