20X30MM BIOMEND EXTEND 0141

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-26 for 20X30MM BIOMEND EXTEND 0141 manufactured by Integra Neurosciences Pr.

Event Text Entries

[121852653] Dhr - no anomaly was found that could lead to the reported condition. Based on the documentation review, the finished good met all product specifications. Dhr review confirmed that expiration date of product was december 31, 2017. Failure analysis is not possible because complaint unit will not be returned for evaluation. A complaint review board (crb) meeting was held and complaint was discussed. Based on complaint information provided and documentation review, product was used expired, and integra does not guarantee the physical properties of the product beyond its expiration date. Based on that it was determined that retain sample evaluation was not required. Even though, visual inspection was performed to the retain samples and confirmed no anomalies within the packaging, sealing or color of the product. Root cause - based on investigation and complaint information provided, we are able to determine root cause for this event is expired product used by the customer leading to a surgery revision.
Patient Sequence No: 1, Text Type: N, H10


[121852654] It was reported that on (b)(6) 2018 patient went to the emergency room because the product came out of the wound. On (b)(6) 2018 patient underwent a general anesthesia intervention in order to remove the bone material and to perform a bone augmentation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1121308-2018-00092
MDR Report Key7912411
Date Received2018-09-26
Date of Report2018-09-07
Date of Event2018-09-05
Date Mfgr Received2018-09-27
Device Manufacturer Date2015-11-25
Date Added to Maude2018-09-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER VIVIAN NELSON
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA NEUROSCIENCES PR
Manufacturer StreetROAD 402 NORTH, KM 1.2
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name20X30MM BIOMEND EXTEND
Generic NameDENTAL PRODUCTS
Product CodeLYC
Date Received2018-09-26
Catalog Number0141
Lot Number1154163
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA NEUROSCIENCES PR
Manufacturer AddressROAD 402 NORTH, KM 1.2 ROAD 402 NORTH, KM 1.2 ANASCO PR 00610 US 00610


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-26

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