MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-19 for OSFERION A2 manufactured by Olympus Terumo Biomaterials Corp. Mishima Factory.
[184252519]
The device (referenced in this report) was not returned to olympus terumo biomaterials corp. For evaluation. The device history record was reviewed, and no irregularities were noted. The osferion bone void filler package insert status in the warning and precaution section: (11) osferion must not be used after the expiration date. This report is being submitted as a medical device report is an abundance of caution. We submitted the initial report on dec 4th 2017. This is resubmission.
Patient Sequence No: 1, Text Type: N, H10
[184252520]
Device used after expiration date. A device past expiry was implanted during surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007738819-2017-00018 |
| MDR Report Key | 9857966 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-19 |
| Date of Report | 2017-11-13 |
| Date of Event | 2017-11-13 |
| Date Mfgr Received | 2017-11-13 |
| Device Manufacturer Date | 2012-05-09 |
| Date Added to Maude | 2020-03-19 |
| 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 | MR. JIRO HIRAI |
| Manufacturer Street | 1-50-1 SASAZUKA,SHIBUYA-KU |
| Manufacturer City | TOKYO, 151-0073 |
| Manufacturer Country | JA |
| Manufacturer Postal | 151-0073 |
| Manufacturer G1 | OLYMPUS TERUMO BIOMATERIALS CORP. |
| Manufacturer Street | 1-50-1 SASAZUKA,SHIBUYA-KU |
| Manufacturer City | TOKYO, 151-0073 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 151-0073 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSFERION |
| Generic Name | FILLER, BONE VOID, CALCIUM COMPOUND |
| Product Code | MQV |
| Date Received | 2020-03-19 |
| Catalog Number | A2 |
| Lot Number | M12313A906 |
| Device Expiration Date | 2017-03-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY |
| Manufacturer Address | 454-1 HIGASHINO,NAGAIZUMI-CHO SUNTO-GUN SHIZUOKA, 411-0931 JA 411-0931 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |