MAUDE Adverse Event Report: HYPERBRANCH MEDICAL TECHNOLOGY INC. ADHERUS AUTOSPRAY DURAL SEALANT

Model Number NUS-106

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

Device not available for evaluation.Device disposed of by healthcare facility.Hyperbranch completed its internal investigation on 19-may-2016.A review of the device history records has been performed.This review confirmed that this lot of product was reviewed and released according to qa specifications.A review of historical complaint data displayed no increase in trends.A retain unit of the same lot was tested and found to conform to specifications.Conclusion: the product in question was not returned for evaluation; therefore, the specific cause for the problem reported could not be identified.If additional information is obtained, or the sample is returned, this investigation will be re-opened.

Event Description

During a chiari procedure, the nus-106 adherus autospray dural sealant was alleged not to polymerize.The product was removed via aspiration.

• Brand Name: ADHERUS AUTOSPRAY DURAL SEALANT
• Type of Device: DURAL SEALANT
• Manufacturer (Section D): HYPERBRANCH MEDICAL TECHNOLOGY INC.; 800-12 capitola dr.; durham NC 27713
• Manufacturer (Section G): HYPERBRANCH MEDICAL TECHNOLOGY INC.; 800-12 capitola dr.; durham NC 27713
• Manufacturer Contact: rob naslund ; 800-12 capitola dr.; durham, NC 27713 ; 9194333332
• MDR Report Key: 5669468
• MDR Text Key: 45594520
• Report Number: 3005920920-2016-00003
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: NUS-106
• Device Catalogue Number: NUS-106
• Device Lot Number: 05151534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 13 YR