MAUDE Adverse Event Report: INTEGRA - PRINCETON DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5; DURASEAL SPINE

Catalog Number 206520

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

Duraseal exact spine sealant system 5ml us box of 5 (206520) was not returned; therefore, an evaluation of the device could not be performed.The facility provided a lot number but same is deemed invalid; therefore, device history record (dhr) could not be reviewed.However all dhrs' are reviewed before release to meet acceptance criteria at the time of manufacturing, and records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.A picture was provided that confirmed the failure mode; however, the root cause is undetermined since product was not received for analysis and the investigation could not confirm the complaint.Per the dfmea, potential causes of failure include: performance [swelling, in-vitro hydrolysis - disappearance, biocompatibility, packaging performance [packaging integrity], sterilization [system and kit].The risk remains acceptable per the risk analysis.If additional information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

This report is 2 of 2 linked to mfg report number 3003418325-2024-00003: a facility reported that during an unspecified surgery it was discovered that duraseal exact spine sealant system 5ml us box of 5 (206520) came with the bottle almost without "powder vial" to prepare (lot# 60474163).When looking for another product in their warehouse, they found that several units were solidified (lot# 60503112).There was no patient injury and surgical delay is unknown.

Event Description

Na.

Manufacturer Narrative

Additional information received: "about the unit of (b)(6) lot 60474163 that failed on surgery, this one was discarded.There is the information about this one: 1.On surgery was detected the failure of the product but the procedure was completed using another unit that was fine.2.It was no delay because we had another backup unit." investigation findings: the duraseal exact spine sealant ((b)(6)) was not returned for investigation as the product was discarded; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.Per the dfmea, potential causes of failure include: performance [swelling, in-vitro hydrolysis - disappearance, biocompatibility, packaging performance [packaging integrity], sterilization [system and kit].If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18797935
• MDR Text Key: 337311460
• Report Number: 3003418325-2024-00004
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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: 206520
• Device Lot Number: 60474163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/22/2024
• Date Device Manufactured: 07/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1