MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 1 PAC; N/A

Catalog Number DP1013

Device Problems Device Expiration Issue (1216); Shelf Life Exceeded (1567)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/07/2017

Event Type  malfunction  

Event Description

The product was placed on (b)(6) 2017 and had an expiration date of mar2017.Several attempts were made to obtain information from the customer with no response.

Manufacturer Narrative

Investigation completed 8/3/2017.The device was not returned for evaluation.As per complaint, it was implanted.Device history record review: device history record (dhr) of lot number 1140925 was reviewed.Lot number: 1140925, catalog number: dp-1013, manufacturing (packaging) date: march 24, 2014, expiration date: march 31, 2017.The manufacturing and final pack processes ran normally; no anomalies were found during manufacturing process of the product.All labels included in the shop order had the correct expiration date.Review of product's ncr, and capa history from june 2015 ¿ june 2017: no related ncr or capa was found to have been opened during the period of june 2015 to june 2017.Upon review of integra's complaint system from june 2015 to june 2017, there are three (3) dural repair product family complaints (including the one under evaluation) related to the use of expired product.The complaint occurrence rate for this type of incident is then 0.00056%.No unusual event related to the reported failure was noticed during the lot records review.As part of manufacturing/packaging documentation, samples of printed material are attached to the dhr and all showed the correct expiration date (same as reported by the customer: 03-2017).The last shipment of lot 1140925 to travis air force base was completed by september 2014.The customer is not actually questioning the product or expiration date; instead, the customer is asking regarding possible consequences of having used an expired product.The product was used at 39 months (expiry period is 36 months).There is a stability study (sp-025) which has successful results up to 42 months at room temperature (including sterility).Nonetheless, it is not recommended to use the product beyond the established expiration date.

• Brand Name: DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 1 PAC
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6720195
• MDR Text Key: 80408691
• Report Number: 1121308-2017-00011
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• PMA/PMN Number: K092388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: DP1013
• Device Lot Number: 1140925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• 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