MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF 5; DURASEAL SPINE

Catalog Number 206320

Device Problems Failure To Adhere Or Bond (1031); Appropriate Term/Code Not Available (3191)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/22/2016

Event Type  Injury  

Event Description

Duragen onlay and duraseal (on the suture) were used for a dural closure on the posterior cranial fossa.At 10 days, cerebrospinal fluid leak appeared.Surgical intervention was required.The leak was below the graft.The product will not be returned for evaluation.Additional information obtained on 26aug2016 from a non-integra sales representative: it is unknown if the patient has an allergic history.This was a personal remark made by the sales representative.The patient had a fistula repair.In the revision surgery, the leak was sealed with fibrin glue.This was the first time the product was used by the doctor.It was reported that the doctors are aware that this event is expected and they are willing to keep using the products.A conference call was initiated to obtain further information.However, the doctors were unavailable at the time.Request for additional information has been requested from the sales representative and on 13sep2016, the following was provided: duragen onlay 7.5cm x7.5 cm (product id not provided) with lot number 1133190 was used.It was confirmed that duraseal (product id: 206320 duraseal exact spine sealant system) was used on this patient in the cranial area.The csf leak was discovered due to a visible globe observed.Relevant diagnostic and lab tests were requested but the sales representative stated they do not have access to this information.The original surgery when the duragen and duraseal were used and implanted was on (b)(6) 2016.The date of the revision surgery where fibrin glue was used was on (b)(6) 2016.Patient outcome was reported as good.Duragen will not be available to be returned for evaluation.Linked to mfg report numbers: 1121308-2016-00017 (same patient) and 3003418325-2016-00023 (same reporter, similar issue, different patients).

Manufacturer Narrative

Additional information received 27sep2016 clarifying date of surgery, date of incident, and reoperation date: surgery date was on (b)(6) 2016.The date of occurrence of the adverse event was on (b)(6) 2016.Reoperation date on (b)(6) 2016.

Manufacturer Narrative

Investigation completed 03/15/2017.The product sample or additional supporting materials from the account was not available.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Without the physical product, a definitive root cause could not be identified.Historical complaint data displayed no trend for the complaint mode.Pmv will continue to monitor this condition for future potential action.

• Brand Name: DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF 5
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5952795
• MDR Text Key: 54879452
• Report Number: 3003418325-2016-00022
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P040034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 206320
• Device Lot Number: N6D0469X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR