MAUDE Adverse Event Report: STRYKER CMF US ADHERUS AUTOSPRAY ET DURAL SEALANT

Catalog Number NUS-109

Device Problem Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported that the product was applied on top of the dura.Surgeon checked on patient days later and noticed that the product had dissolved sooner than expected.

• Brand Name: ADHERUS AUTOSPRAY ET DURAL SEALANT
• Type of Device: DURAL SEALANT
• Manufacturer (Section D): STRYKER CMF US; micro implants; 750 trade centre way suite 200; portage MI 49002
• Manufacturer (Section G): STRYKER CMF US; micro implants; 750 trade centre way suite 200; portage MI 49002
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 15158818
• MDR Text Key: 297352371
• Report Number: 0008010177-2022-00026
• Device Sequence Number: 1
• Product Code: HMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 130014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NUS-109
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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