MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2015-04-13 for ORTHOBLAST-II PASTE 02-2100-010 manufactured by Isotis Orthobiologics, Inc.
[5649529]
This is the fifth of 5 reports for this product problem (ref pt id: (b)(6). It was reported that following an interbody fusion surgery there was infection, pus was found. The product is still implanted in the pt. It was reported the current opinion is the problem is not because of the orthoblast product. The infected pts are all elderly, over 70 years old, and have had combined orthopedic surgery (posterolateral fusion, interbody fusion with bone substitute). Add'l info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[13146843]
The device will not be returned since it remains implanted. Based on reported info, integra has initiated an investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090010-2015-00005 |
| MDR Report Key | 4691860 |
| Report Source | 01,06,07,08 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-03-16 |
| Date Mfgr Received | 2015-03-16 |
| Date Added to Maude | 2015-04-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOBLAST-II PASTE |
| Generic Name | ORTHOBLAST |
| Product Code | MBP |
| Date Received | 2015-04-13 |
| Catalog Number | 02-2100-010 |
| Lot Number | 141899(SUSPECTED LOT) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-13 |