MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-09 for MEDTRONIC NAVIGATION UNK_OARM_SYS manufactured by Medtronic Navigation, Inc (littleton).
[178749788]
Patient information was not included in the journal article. This value is the median age of the patients reported in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Please note that this date is based off of the date the article was published as the event dates were not provided in the published literature. Article citation is included. No product code provided as the system is unknown. System product number and serial number not provided in journal article. Udi not available for this system. No 510k provided as system is unknown. No evaluation was performed as this event was reported in literature. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178749789]
Citation: wanru duan, yueqi du, tengfei qi, bowen jiang, kai wang, zhenlei liu, jian guan, xingwen wang, hao wu, zan chen, fengzeng jian, the value and limitation of cervical traction in the evaluation of the reducibility of atlantoaxial dislocation and basilar invagination using the intraoperative o-arm, world neurosurgery, volume 132, 2019, pages e324-e332, issn 1878-8750, https://doi. Org/10. 1016/j. Wneu. 2019. 08. 160. Summary: objective: to assess the value and limitation of cervical traction in the evaluation of the reducibility of atlantoaxial dislocation (aad) and basilar invagination (bi) using the intraoperative o-arm. Methods: a total of 22 patients with hyperextensive, irreducible aad were included. The cervical traction test under general anesthesia was performed, and the degree of reduction was evaluated using the o-arm before the operation started. The traction effects both vertically and horizontally were evaluated. All cases then underwent modified direct posterior reduction and fixation. Clinical outcomes were evaluated using the japanese orthopaedic association (joa) scale. Radiologic measurements included the anterior atlantodental interval, the distance of odontoid tip above chamberlain line, and the clivusecanal angle. Magnetic resonance imaging signal changes, size of syringomyelia, and the space ventral to medulla also were used to evaluate the postoperative reduction result. Results: after the cervical traction test, 7 patients achieved incomplete reduction, 5 achieved only vertical reduction, 6 achieved only horizontal reduction, and 4 achieved complete reduction in both horizontal and vertical orientations as assessed by the o-arm. All patients underwent a direct reduction technique. The mean joa score increased from 11. 1 to 14. 5. Complete reduction of aad and bi were achieved in 19 patients (86. 4%), with partial reduction achieved in 3 (13. 6%). Sufficient cerebrospinal fluid space anterior to the medulla with improved joa score was achieved in the 3 partially reduced patients. Conclusions: with the innovations of direct posterior reduction techniques, cervical traction under anesthesia may not sufficiently predict the reducibility of bi and aad. Cervical traction still plays an important role during the direct posterior reduction procedure. Reported events: one patient had superficial infection and recovered in one month after antibiotic therapy. Six patients complained of neck pain immediately after surgery with resolution of the pain at 3 months. One patient had posterior superior iliac crest pain that resolved in one month.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00036 |
| MDR Report Key | 9569290 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-09 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Manufacturer Street | 300 FOSTER ST |
| Manufacturer City | LITTLETON MA 01460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC NAVIGATION |
| Product Code | IZL |
| Date Received | 2020-01-09 |
| Model Number | UNK_OARM_SYS |
| Catalog Number | UNK_OARM_SYS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Manufacturer Address | 300 FOSTER ST LITTLETON MA 01460 US 01460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |