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.
[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
| Report Number | 1121308-2018-00092 |
| MDR Report Key | 7912411 |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2015-11-25 |
| Date Added to Maude | 2018-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES PR |
| Manufacturer Street | ROAD 402 NORTH, KM 1.2 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 20X30MM BIOMEND EXTEND |
| Generic Name | DENTAL PRODUCTS |
| Product Code | LYC |
| Date Received | 2018-09-26 |
| Catalog Number | 0141 |
| Lot Number | 1154163 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES PR |
| Manufacturer Address | ROAD 402 NORTH, KM 1.2 ROAD 402 NORTH, KM 1.2 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-26 |