MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-26 for BIO DBM PUTTY 10CC 7775010 manufactured by Stryker Spine-us.
[74015824]
It was reported that; dr. Booked lumbar fusion and said must used dbm putty. We ordered dbm putty last week for case but the 10cc putty we ordered was on b/o so we didn't receive that. We had 20cc total (5cc size), so as a back up we had a courier bring 10cc putty from (b)(6) the morning of (b)(6) 2017. As the case went on we opened all 5cc sizes and dr. Said he needed more so then the borrowed 10cc was opened for case. This was done so before the hospital could input the product in their system. Later on in day we got a call from hospital asking where we got the dbm from. Rep explained how we got the product, that a piece of tissue was transferred from one hospital to another.
Patient Sequence No: 1, Text Type: D, B5
[115806206]
Patient Sequence No: 1, Text Type: N, H10
[115806207]
It was reported that; dr. (b)(6) lumbar fusion and said must used dbm putty. We ordered dbm putty last week for case but the 10cc putty we ordered was on b/o so we didn't receive that. We had 20cc total (5cc size), so as a back up we had a courier bring 10cc putty from (b)(6) the morning of (b)(6) 2017. As the case went on we opened all 5cc sizes and dr. Said he needed more so then the borrowed 10cc was opened for case. This was done so before the hospital could input the product in their system. Later on in day we got a call from hospital asking where we got the dbm from. Rep explained how we got the product, that a piece of tissue was transferred from one hospital to another.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004024955-2017-00018 |
| MDR Report Key | 6522682 |
| Date Received | 2017-04-26 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-04-18 |
| Date Mfgr Received | 2017-04-18 |
| Date Added to Maude | 2017-04-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARTA KOUTSOGIANNIS |
| 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 | 0 |
| Brand Name | BIO DBM PUTTY 10CC |
| Generic Name | RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE |
| Product Code | MBP |
| Date Received | 2017-04-26 |
| Model Number | 7775010 |
| Catalog Number | 7775010 |
| Lot Number | 1571706528 |
| 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 | 2017-04-26 |