MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7; INSTRUMENT, STEREOTAXIC

Model Number 9733858

Device Problem Imprecision (1307)

Patient Problems Hematoma (1884); Iatrogenic Source (2498); Foreign Body In Patient (2687)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

Patient information: patient information was not included in the journal article.Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date the article was accepted as the event dates were not provided in the published literature.Description of problem or event: article citation is included.Serial #, udi #: serial number not provided in journal article.Udi not available for this system.Concomitant medical products: other relevant device(s) are: product id: unk_nav_comp, serial/lot #: unknown, ubd: unknown, udi #: unknown.Device evaluated by mfr: no evaluation was performed as this event was reported in literature.Manufacture date: device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: balling, horst.¿additional sacroplasty does not improve clinical outcome in minimally invasive navigation-assisted screw fixation procedures for nondisplaced insufficiency fractures of the sacrum.¿ spine, vol.44, no.8, 2019, pp.534¿542., doi:10.1097/brs.0000000000002899.Summary: study design: prospective single-center cohort study (noninferiority study).Objective: to compare clinical results of navigation-assisted screw fixation (nsf) to those of nsf with additional sacroplasty (nsf + sp) for immobilizing nondisplaced insufficiency fractures of the sacrum.Summary of background data: nsf for sacral insufficiency fractures is a new, technically demanding procedure requiring surgical skills and experience.Up to date, controversies exist about the benefit of additional sacroplasty in surgically stabilized insufficiency fractures of the sacrum.Methods: from february 2011 to may 2017, all individuals with immobilizing nondisplaced sacral insufficiency fractures surgically treated using 3d-fluoroscopy for 3d-real-time navigation and postinstrumentation screw control in the form of nsf (i) or nsf sp (ii) were enrolled.Sp was performed only in absence of transforaminal or central fractures.Outcome parameters were postsurgical pain relief determined by visual analog scale, postsurgical improvement of disability evaluated using the oswestry disability index, and length of postsurgical hospital stay.Results: in 2 groups of 26 individuals, each, a total of 124 insufficiency fractures of sacral vertebrae were surgically treated.Postoperative pain-level decrease was comparable in both groups (5.3 vs.5.4 visual analog scale points).Extent of postoperative disability score improvement (53.4 vs.57.7 oswestry disability index points) led to successful remobilization after similar durations of postsurgical hospital stay (9.3 vs.9.6 days).Minimum clinically important differences of outcome parameters were not reached in the comparison of study group results.In procedures with sp, no major complications occurred, in those without sp, no specific complications were observed.Conclusion: this comparative study indicates noninferiority of nsf compared to nsf + sp for sacral insufficiency fractures, and could not confirm clinical advantages of additional sp concerning pain relief, improvement of fracture-related disability, or time from surgery to discharge.Therefore, additional sacroplasty is not recommended to enhance the clinical benefit for patients receiving image-guided sacral screw fixation.Events: one patient in group one (nsf) had complication of comprised posterior guidewire malplacement with breach of the spinal canal necessitating intraoperative correction after control scanning.One patient in group one (nsf) with postsurgical subfascial hematoma formation that was addressed by surgical evacuation on post-operative day 9.Two patients in group two (nsf + sp) with cement extrusions into the spinal canal which were asymptomatic.Two patients in group two (nsf + sp) with cement extrusions into peripelvic soft tissue which were asymptomatic.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that for performing the surgeries mentioned in the article, the imaging system and the navigation unit from medtronic were used.No adverse events concerning these devices were observed, nor did any adverse events mentioned within the article directly relate to medtronic products.Instruments and implants used for surgeries were non-medtronic products.

• Brand Name: STEALTHSTATION® S7
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8800724
• MDR Text Key: 151416946
• Report Number: 1723170-2019-04117
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2019
• 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
• Patient Age: 76 YR