MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-27 for BIO DBM PUTTY 1CC 7775001 manufactured by Stryker Spine-us.
[58927278]
It was reported that; during a one level mis tlif case with doctor, he requested a 2 or 3 cc 's of dbm available to mix with his autograft so as the case began four boxes of 1 cc bio dbm were brought from where it is stored at the hospital. We got to the point where we needed to open graft and two 1cc bio dbm grafts were requested to open to the field. Randomly grabbed two boxes out of the four in the room and handed them to circulator to open. I then left the room to go grab cages to bring in. By the time i got back the graft was open and on the field. I put stickers on my charge sheet and continued with the case. I did not open, or log into the hospital tissue tracking book any of the tracking information. I was notified that one of the grafts we used was expired on 9/15/16.
Patient Sequence No: 1, Text Type: D, B5
[65822414]
Method: device history review, complaint history review, risk assesment; result: it was confirmed that the product was implanted into a patient past it's expiration date. It was confirmed that the product was manufactured to specification. Conclusion: it is unknown how this occurred. It is possible the hospital staff moved it, but this cannot be confirmed or denied.
Patient Sequence No: 1, Text Type: N, H10
[65822415]
It was reported that; during a one level mis tlif case with doctor, he requested a 2 or 3 cc 's of dbm available to mix with his autograft so as the case began four boxes of 1 cc bio dbm were brought from where it is stored at the hospital. We got to the point where we needed to open graft and two 1cc bio dbm grafts were requested to open to the field. Randomly grabbed two boxes out of the four in the room and handed them to circulator to open. I then left the room to go grab cages to bring in. By the time i got back the graft was open and on the field. I put stickers on my charge sheet and continued with the case. I did not open, or log into the hospital tissue tracking book any of the tracking information. I was notified that one of the grafts we used was expired on 9/15/16.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004024955-2016-00097 |
| MDR Report Key | 6062016 |
| Date Received | 2016-10-27 |
| Date of Report | 2017-01-13 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-10-18 |
| Device Manufacturer Date | 2016-01-05 |
| Date Added to Maude | 2016-10-27 |
| 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. RAKSHYA BISTA |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608000 |
| Manufacturer G1 | STRYKER SPINE-US |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO DBM PUTTY 1CC |
| Generic Name | RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE |
| Product Code | MBP |
| Date Received | 2016-10-27 |
| Catalog Number | 7775001 |
| Lot Number | 1535846547 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SPINE-US |
| Manufacturer Address | 2 PEARL COURT ALLENDALE NJ 07401 US 07401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-27 |