MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURAGEN 3X3 1 PACK CE; N/A

Catalog Number ID3301I

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Laceration(s) (1946)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report no.: 1121308-2019-00048.

Event Description

This is 1 of 2 reports.A distributor reported on behalf of the customer that both id4501i duragen 4x5 ("primary product") and id3301i duragen 3x3 ("combination product") were used on (b)(6) 2019 for an external decompression for obstructive hydrocephalus due to hemorrhagic cerebral infarction and brain hernia.On (b)(6) 2019, a craniotomy and scalp detachment procedure were performed.They found severe adhesions between the scalp and regenerated dura where the duragens were placed.The male patient had incurred a dural laceration due to the surgery to remove the adhesions.The cranioplasty was delayed for over 30 minutes.New duragen was used on the patient for the re-dura formation.The patient was being closely monitored.

Manufacturer Narrative

The device was not returned for evaluation.The dhr review was not possible because the lot numbers for the catalogs reported were not provided by the customer.The complaint is considered unconfirmed.The root cause for this event is unknown.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa (b)(4) have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(6) mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: DURAGEN 3X3 1 PACK CE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• MDR Report Key: 10276238
• MDR Text Key: 204049193
• Report Number: 1121308-2019-00047
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• PMA/PMN Number: K982180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ID3301I
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1