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.
[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
| Report Number | 1526439-2020-00694 |
| MDR Report Key | 9820004 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 02400 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN MONO/POLYAXIAL SCREWS |
| Generic Name | ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION |
| Product Code | MNH |
| Date Received | 2020-03-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |