MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

Device Problem Imprecision (1307)

Patient Problem Numbness (2415)

Event Date 09/23/2020

Event Type  Injury  

Event Description

Lu, s., yang, k., lu, c., wei, p., gan, z., zhu, z., tan, h.(2021, february 17).O-arm navigation for sacroiliac screw placement in the treatment for posterior pelvic ring injury.International orthopaedics.Retrieved december 6, 2021, from https://link.S pringer.Com/article/10.1007/s00264-020-04832-2.Summary purpose: this study aims to investigate the application value of o-arm navigation system in sacroiliac screw placement for the treatment of unstable pelvic ring injury.Methods a total of 40 patients (mean age = 30.75 ± 14.99 years, 25 males, 15 females) were included.From january 2016 to july 2018, 40 patients with posterior pelvic ring injury treated in our hospital were included.Of them, 19 patients underwent o-arm navigation for screw placement (o-arm group) while the other 21 received c-arm fluoroscopy guidance (c-arm group) for sacroiliac screw placement.Intraoperative outcomes and the outcome of screw placement were compared between groups.The quality of radiological images was assessed by matta¿s radiological outcome grade.The outcome of complex pelvic fracture treatment was evaluated by majeed functional score.Results: all demographic and clinical characteristics were comparable between the two groups.Compared with the c-arm groups, the o-arm group had a shorter surgery time (33.19 ± 3.14 vs.48.35 ± 4.38 min, p <(><<)> 0.001), a higher overall good outcome ¿excellent + good¿ rate of screw placement (95.45% vs.73.91%, p <(><<)> 0.05), and a significantly higher majeed functional score better outcome of complex pelvic fracture treatment at 1 and 3 months postoperation (both p <(><<)> 0.05).Conclusion: our results demonstrated that o-arm navigation system is feasible and safe for the treatment of posterior pelvic ring injury and can effectively improve the accuracy and safety of sacroiliac screw placement, shorten the operation time, and help rapid postoperative functional recovery.Reported event nineteen patients underwent a sacroiliac screw placement to address an unstable pelvic ring injury.It was reported that one patient had to undergo a screw revision due to screw malposition.The screw clearly penetrated the sacral pedicle, more than one-fourth of the screw diameter.This issue was attributed to the surgical assistant accidentally hitting the reference frame, leading to image drift, and then screw malposition.It was also noted that there were two cases of numbness and predehydration.These issues were resolved by symptomatic treatments, such as hormone and nutritional nerve treatment for three months.

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the average age of the patients who underwent a sacroiliac screw placement as specific patients could not be identified.This value reflects the majority gender of the patients who underwent a sacroiliac screw placement as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the accepted date.The article citation is included.The serial number was not provided in the journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12934359
• MDR Text Key: 287181733
• Report Number: 1723170-2021-02820
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 31 YR
• Patient Sex: Male