MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-11-27 for BUDDE HALO RETRACTOR SYSTEM XXX-BUDDE manufactured by Integra Lifesciences Corporation Oh/usa.
[128460451]
It is unknown if the device will be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Doi: https://doi. Org/10. 1016/j. Wneu. 2018. 01. 069.
Patient Sequence No: 1, Text Type: N, H10
[128460452]
World neurosurgery (2018) published "the radiographic effects of surgical approach and use of retractors on the brain after anterior cranial fossa meningioma resection" which evaluated the radiographic changes over time after surgical resection of anterior cranial fossa meningiomas with and without both skull base (sb) approaches and/or fixed retractor systems. All adults patients (age greater than 18 years) undergoing primary resection of an anterior cranial fossa world health organization (who) grade i meningioma (olfactory groove, planum sphenoidal, "tuberulum" sella, and clinoid) through a craniotomy at a single academic tertiary-care institution between 2010 and 2015 were retrospectively reviewed. Tumor location was based on pre-operative radiology reports and on the anticipated tumor origin. The clinical, operative, and hospital course of records of the patients who met the inclusion criteria were retrospectively reviewed. Magnetic resonance imaging scans were typically performed within 48 hours before surgery, 48 hours after surgery, and 3 as well as 9-12 months postoperatively. The images were obtained and the characteristics that were recorded included the preoperative tumor (volume contrast enhancement, excluding the dural tail if present) and fluid-attenuated inversion recovery (flair) volume (volume of flair excluding the tumor enhancing volume) of the lesion, postoperative tumor and flair volumes, postoperative presence of ischemia (presence of diffusion-weighted hyperintensity and absence of hyperintensity on apparent diffusion coefficient techniques), 3-month postoperative tumor and flair volumes. Sb approaches were defined as those involving orbital osteotomies (orbitozygomatic, modified orbitozygomatic, transzygomatic, or extended bifrontal), whereas those involving only drilling down of the orbital roof as well as anterior or middle cranial fossa were not considered sb approaches. The use of a fixed retractor system (leyla, braun; symmetry surgical, antioch; budde, integra) was determined based on operative reports. The use of sb approaches and fixed retractor systems was based on surgeon preference. When fixed retractor systems were not used, dynamic retraction was chosen with the use of handheld instruments. Results: the average age of all patients was 55. 9 +/- 11. 7 years at the time of surgery, and 39 (29%) were male. Of the 136 total patients, 20 (15%), 12 (9%), 46 (34%), and 58 (43%) underwent sb/retractorless, sb/ra, non-sb/retractorless, and non-sb/ra surgery, respectively. Patients who underwent non-sb and ra surgery each independently had longer times to flair resolution than those who underwent sb (20. 9 vs. 5 months; p 0. 04) and retractorless (12 vs. 5. 2 months; p 0. 02) surgery, respectively. Patients who underwent both non-sb and ra surgery had the longest median time to flair resolution (30 months vs. 4 months in sb/retractorless, 3. 6 months in sb/ra, and 3 months in non-sb/retractorless; p < 0. 05). Post-operative symptoms of patients who underwent anterior fossa meningioma resection with and without skull base approaches and retraction -assisted surgery: skull base/retractor (n=12): one (1) new motor deficit, one (1) seizures, four (4) length of hospital stay, days. Non-skull base/retractor (n=58): seven (7) new motor deficit, five (5) new language deficit, one (1) new vision deficit, four (4) seizures, and three (3) length of hospital stay, days. Conclusion: the use of sb approaches in combination with retractorless surgery may decrease the duration needed for flair resolution after surgery. The results from this study therefore advocate sb approaches and retractorless surgery along the anterior sb when possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2018-00267 |
| MDR Report Key | 8107473 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-08 |
| Date Mfgr Received | 2018-12-27 |
| Date Added to Maude | 2018-11-27 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUDDE HALO RETRACTOR SYSTEM |
| Generic Name | RETRACTOR SYSTEMS |
| Product Code | GZT |
| Date Received | 2018-11-27 |
| Catalog Number | XXX-BUDDE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-27 |