MAUDE Adverse Event Report: STRYKER CMF US ADHERUS AUTOSPRAY; NQR

Catalog Number NUS-106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

Stryker cmf recently acquired hyperbranch, and this mdr is a result of the remediation process.Hyperbranch had identified this complaint (number: (b)(4)) as non- reportable.Upon further development of the risk files, stryker has decided to file a report.The observation stated in the reported event could not be confirmed, because the information provided was not sufficient.On several different occasions additional information was requested, however the complainant did not respond.The only material received from the complainant was the hyperbranch medical device complaint form.A dhr review was performed for all potentially affected lots.As the device was manufactured by stryker durham (usa), the available complaint information was forwarded to the manufacturing site to review the related quality and manufacturing documents.Within the review no deviations were found, the required tests were performed and did pass without any discrepancies.Based on the limited information provided and the lack of provided follow-up the root cause of this complaint cannot be determined.Considering the investigation including a statistical analysis and the dhr review of the related quality and manufacturing documents there is no indication that the product is not working as intended or any systematic design, material or manufacturing related issue exists.The complaint is added to the complaint trend.Device unable to be returned for evaluation.

Event Description

It was reported that the patient had a csf leak 4 days post-surgery.A revision surgery was performed, and it was noted that no suture was loose.The adherus was replaced with fibrin glue.

Event Description

It was reported that the patient had a csf leak 4 days post-surgery.A revision surgery was performed, and it was noted that no suture was loose.The adherus was replaced with fibrin glue.

Manufacturer Narrative

The observation stated in the reported event could not be confirmed, because the information provided was not sufficient.On several different occasions additional information was requested, however the complainant did not respond.The only material received from the complainant was the hyperbranch medical device complaint form.A dhr review was performed for all potentially affected lots.As the device was manufactured by stryker durham (usa), the available complaint information was forwarded to the manufacturing site to review the related quality and manufacturing documents.Within the review no deviations were found, the required tests were performed and did pass without any discrepancies.Based on the limited information provided and the lack of provided follow-up the root cause of this complaint cannot be determined.Considering the investigation including a statistical analysis and the dhr review of the related quality and manufacturing documents there is no indication that the product is not working as intended or any systematic design, material or manufacturing related issue exists.The complaint is added to the complaint trend.

• Brand Name: ADHERUS AUTOSPRAY
• Type of Device: NQR
• Manufacturer (Section D): STRYKER CMF US; micro implants; 750 trade centre way suite 200; portage MI 49002
• MDR Report Key: 8845653
• MDR Text Key: 152777799
• Report Number: 3005920920-2019-00003
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• PMA/PMN Number: P130014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NUS-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention