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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Neuromodulation Corporation Superion IDS Kit

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  Class 2 Device Recall Boston Scientific Neuromodulation Corporation Superion IDS Kit see related information
Date Initiated by Firm May 12, 2023
Date Posted June 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-1972-2023
Recall Event ID 92181
PMA Number P140004 
Product Classification Prosthesis, spinous process spacer/plate - Product Code NQO
Product Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Code Information Driver UDI-DI: 00884662000574, UPN: 102-9800, All Lots. Superion Indirect Decompression System IFU (92479815-02), Superion IDS Kit IFU (92479820-02), Surgical Technique Manual (92479821-02)
Recalling Firm/
Manufacturer		 Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia CA 91355-5004
For Additional Information Contact Rebecca KinKead Rubio
651-581-0761
Manufacturer Reason
for Recall		 Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
FDA Determined
Cause 2		 Labeling design
Action On 05/12/23, correction notices were mailed to physicians/surgeons, hospitals, healthcare professionals who were advised the following: IFU advises against forced deployment, as it could result in device breakage. Correction notice advises to review of the IFUs/Surgical Technique Manual. Avoid application of excessive force, use only two or three fingers when performing final tightening during device deployment). Inspect Driver instrument prior to/following use; if Driver tip break is noted: Retrieve metal fragment(s), consider performing imaging. Missing/bent teeth prevents Driver engagement with implant and requires exchange for a new/replacement Driver instrument to complete successful deployment. If metal fragment(s) are not successfully removed: MRI scans are NOT advised, Append the patient s medical record with a copy of this letter to maintain awareness of metal fragment(s) remaining in situ for the remaining service life of the device. Consider alternative imaging for patients with metal fragment(s) remaining in situ, e.g., X-ray/ultrasound/CT scan. Distributors asked to notify all customers that have been shipped/sold affected product. Complete/return acknowledgement form to BSCFieldActionCenter@bsci.com or Fax to: Field Action Center (1-866-213-1806). Driver tip breakage can be identified via an audible click, a loss of tactile resistance during the implant procedure, and/or visual detection following removal of the Driver instrument from the inserter tool and subsequent inspection. Adverse events or quality concerns should be reported to BSN.ComplaintCallCenter@bsci.com. If you have any question, contact Senior Management Quality: at 651-581-0761 or email: rebecca.kinkead@bsci.com Firm is updating IFU to advise against MRI scanning for patients with unretrieved metal fragments. A separate letter was sent to health care professions providing them with a patient letter. Patient letter states firm recommends patients discuss this letter with t
Quantity in Commerce 21,533
Distribution US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK, MO, MI, OH, WV, NC, UT, NH, CA, NJ, TN, NV, AZ, NE, IA, CT, ME, LA, KY, MS, MD, DC, GA, CO, KS, ID, MN, AR, HI, NM, WA, SD, OR, DE, WY, AK, and ND
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NQO and Original Applicant = Boston Scientific Neuromodulation
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