MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURAGEN PLUS, UNKNOWN; N/A

Catalog Number XXX-DURPLUS

Device Problem Device Expiration Issue (1216)

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

Event Type  Injury  

Event Description

It was reported that a hospital implanted a piece of duragen plus 7 days after its labeled expiration date.The patient was undergoing a lumbar decompression.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 27 jul 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: one (1) used package of duragen plus 1 pk, 1x1 (fg lot # 1130383) was reported as the complaint unit.Product package was not returned for evaluation.Therefore, a failure analysis of the complaint unit is not possible.One (1) retain sample was visually inspected for product and packaging appearance.No anomalies were observed.Complaint unit met product and packaging specifications according to qcic 2038 ¿packaged collagen product inspection.¿ date of finished goods (fg) lot 1130383 manufacturing date is 02/17/13 and expiration date is 2016-02.No similar complaints related to ¿used of expired product¿ have been reported for this fg lot # 1130383.After reviewing the integra lifesciences (b)(4) facility complaint system since 03/23/13 until 03/23/16 only this complaint has been reported regarding the condition ¿use of expired product¿ in the duragen plus family at integra lifesciences (b)(4) facility.Approximately (b)(4) units of duragen plus products have been shipped for sales purposes since 03/23/13 until 03/23/16, resulting in a complaint occurrence rate of (b)(4).This was determined by dividing the number of complaints in this category (1) by the number of units shipped for sales purposes of duragen plus products.Conclusion: based on the retain samples evaluation and the dhr review, the reported incident (use of expired product) could not be associated to the manufacturing / packaging process performed at integra (b)(4).Complaint unit was labeled in an accurate manner as per dp1011 device history record (dhr) and applicable procedures.Therefore, it is not possible to confirm the reported condition as an event related to the manufacturing process of fg lot # 1130383.

• Brand Name: DURAGEN PLUS, UNKNOWN
• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5562536
• MDR Text Key: 42376777
• Report Number: 3003418325-2016-00008
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• PMA/PMN Number: K032693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURPLUS
• Device Lot Number: 1130383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2013
• 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): Other