O-ARM IMAGING SYSTEM
Report
- Report Number
- 3004785967-2024-00411
- Event Type
- Injury
- Date Received
- July 12, 2024
- Date of Event
- June 14, 2024
- Report Date
- July 26, 2024
- Manufacturer
- MEDTRONIC NAVIGATION, INC (LITTLETON)
- Product Code
- OXO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H2) CORRECTION MADE TO G3. THE ADDITIONAL INFORMATION WAS RECEIVED JULY 17, 2024. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H2) ADDITIONAL INFORMATION WAS ADDED TO H2. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CORAZZELLI, G., DI NOTO, G., CIARDO, A., COLANGELO, M., CORVINO, S., LEONETTI, S., D¿ELIA, A., RICCIARDI, F., BOCCHINO, A., PAOLINI, S., ESPOSITO, V., INNOCENZI, G. POSTEROLATERAL APPROACHES TO THE THORACIC SPINE FOR CALCIFC DISC HERNIATION: IS WIDER EXPOSURE ALWAYS BETTER? ACTA NEUROCHIRURGICA (2024) 166:267 HTTPS://DOI.ORG/10.1007/S00701-024-06146-3. OBJECTIVE: TO COMPARE THE COSTOTRANSVERSECTOMY (CTV) AND TRANSPEDICULAR (TP) APPROACHES VERSUS THE TRANSFACET (TF) APPROACH FOR THE SURGICAL TREATMENT OF CALCIFC THORACIC SPINE HERNIATIONS (CTDH), IN TERMS OF SURGICAL AND CLINICAL OUTCOMES. BACKGROUND: SURGICAL APPROACHES FOR CTDH ARE DEBATED. ANTERIOR APPROACHES ARE RECOMMENDED, WHILE POSTEROLATERAL APPROACHES ARE PREFERRED FOR NON-CALCIFC, PARAMEDIAN, AND LATERAL HERNIAS. CURRENTLY, THERE IS LIMITED EVIDENCE ABOUT THE SUPERIORITY OF A MORE INVASIVE SURGICAL APPROACH, SUCH AS CTV OR TP, OVER TF, A RELATIVELY LESS INVASIVE APPROACH, IN TERMS OF NEUROLOGICAL OUTCOME, PAIN, AND SUR GICAL COMPLICATIONS, FOR THE TREATMENT OF CTDH. METHODS: A RETROSPECTIVE, OBSERVATIONAL, MONOCENTRIC STUDY WAS CONDUCTED ON PATIENTS WHO UNDERWENT POSTEROLATERAL THORACIC APPROACHES FOR SYMPTOMATIC CTDH, BETWEEN 2010 AND 2023, AT OUR INSTITUTE. THREE GROUPS WERE DRAFTED, BASED ON THE SURGICAL APPROACH USED: TF, TP, AND CTV. ALL PROCEDURES WERE ASSISTED BY INTRAOPERATIVE CT SCAN, SPINAL NEURONAVIGATION, AND INTRAOPERATIVE NEUROMONITORING. ANALYZED FACTORS INCLUDE DURATION OF SURGERY, AMOUNT OF BONE REMOVAL, INTRAOPERATIVE BLOOD LOSS, CSF LEAK, NEED OF INSTRUMENTATION FOR IATROGENIC INSTABILITY, DEGREE OF DISC HERNIATION REMOVAL, MYELOPATHY RECOVERY. AFTERWARDS, A STATISTICAL ANALYSIS WAS PERFORMED TO INVESTIGATE THE BONY RESECTION OF THE SUPERIOR POSTERIOR EDGE OF THE VERTEBRAL SOMA. THE PRIMARY OUTCOME WAS THE PARTIAL OR TOTAL HERNIATION REMOVAL. RESULTS: THIS STUDY CONSECUTIVELY ENROLLED 65 PATIENTS WHO UNDERWENT POSTEROLATERAL THORACIC SURGERY FOR CTDH. THE TF APPROACH TAKING THE LEAST, AND THE CTV THE LONGEST TIME (P<(><<)>0.01). NO STATISTICAL DIFERENCE WAS OBSERVED BETWEEN THE THREE MENTIONEDAPPROACHES, IN TERMS OF INTRAOPERATIVE BLOOD LOSS, DURAL LEAKAGE, POST-RESECTION INSTRUMENTATION, TOTAL HERNIATION REMOVAL, OR MYELOPATHY RECOVERY. AN ADDITIONAL SOMATIC BONY RESECTION WAS SUCCESSFUL IN ACHIEVING TOTAL HERNIATION REMOVAL (P<(><<)>0.01), AND THE EXTENT OF BONY RESECTION WAS DIRECTLY PROPORTIONAL TO THE EXTENT OF HERNIA REMOVAL (P<(><<)>0.01). CONCLUSION: NO STATISTICALLY SIGNIFCANT DIFERENCES WERE HIGHLIGHTED BETWEEN THE TP, TF, AND CTV REGARDING THE EXTENT OF CTDH REMOVAL, THE POSTOPERATIVE COMPLICATIONS, AND THE NEUROLOGICAL IMPROVEMENT. THE DESCRIBED SOMATIC BONE RESECTION ACHIEVED SIGNIFCANT TOTAL HERNIATION REMOVAL AND WAS DIRECTLY PROPORTIONAL TO THE PREOP AGAINST POSTOP ANTEROPOSTERIOR DIAMETER DIFERENCE. REPORTED EVENTS: POST-PROCEDURAL STABILIZATION OF THE THORACIC SPINE WAS REQUIRED IN ONLY THREE CASES (5%). THE INCIDENCE OF CFS LEAK DID NOT DIFFER BETWEEN THE THREE APPROACHES (P=0.04).
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL STATING THAT MEDTRONIC DEVICES/PRODUCTS WERE NOT DIRECTLY RELATED TO THE MENTIONED ADVERSE EVENTS.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL STATING THAT MEDTRONIC DEVICES/PRODUCTS WERE NOT DIRECTLY RELATED TO THE MENTIONED ADVERSE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272209 | O-ARM IMAGING SYSTEM | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M | OXO | MEDTRONIC NAVIGATION, INC (LITTLETON) | UNK_OARM_SYS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Required Intervention |