MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-26 for COLLACOTE 0101 manufactured by Integra Neurosciences Pr.
[100922227]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information. Linked to mfg. Report number 1121308-2018-00012.
Patient Sequence No: 1, Text Type: N, H10
[100922228]
This is 2 of 2 reported complaints. It was reported by a doctor that a 0101 collacote was used on a graft placement with membrane procedure. However, about fifteen days post procedure, it was noted through x-ray that there were punctual cases of serious inflammation, heavy gingival redness and some bone loss around the implants. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[114082068]
Investigation completed on (b)(6) 2018. The device was not returned to the manufacturer for physical evaluation, therefore, the reported condition could not be confirmed and root cause cannot be determined. Device history record review cannot be performed since lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2018-00013 |
| MDR Report Key | 7296209 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-26 |
| Date of Report | 2018-01-29 |
| Date Mfgr Received | 2018-03-08 |
| Date Added to Maude | 2018-02-26 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| 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 | 3 |
| Brand Name | COLLACOTE |
| Generic Name | DENTAL PRODUCTS |
| Product Code | LPG |
| Date Received | 2018-02-26 |
| Catalog Number | 0101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2018-02-26 |