MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-06-02 for ORTHOBLAST-II PASTE 02-2100-080 manufactured by Isotis Orthobiologics, Inc.
[20144209]
It was reported the surgeon implanted a "paste" product, however, afterward he noticed that the product was expired by 2 days. No patient impact was indicated.
Patient Sequence No: 1, Text Type: D, B5
[20462273]
The device will not be returned since it remains implanted. Based on reported information, integra has initiated an investigation.
Patient Sequence No: 1, Text Type: N, H10
[54639596]
Information omitted from initial report in error. The product was not explanted. Integra has completed the internal investigation on 06/11/2015. The additional investigation activities included: methods: review of device history records; review of complaint history. Results: orthoblast ii paste product was manufactured under lot number 130608. The complete device history record was reviewed and no anomalies were noted. The product was manufactured and released in accordance with product specifications. The product is terminally sterilized according to required specifications. When used prior to the expiration date, the probability of having contamination is one in one-million. The complaint database was reviewed for the last two years and there were no related incidents for this product or issue. Conclusion: the product was used "off label".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090010-2015-00007 |
| MDR Report Key | 4817734 |
| Report Source | 05,07 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-05-08 |
| Date Mfgr Received | 2015-05-08 |
| Date Added to Maude | 2015-06-05 |
| 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 | MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOBLAST-II PASTE |
| Generic Name | NONE |
| Product Code | MBP |
| Date Received | 2015-06-02 |
| Catalog Number | 02-2100-080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | IRVINE CA 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-02 |