MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-09 for ALLOGRAFT EVANS WEDGE 10X22X20MM 3102-1910 manufactured by Stryker Orthobiologics-malvern.
[52783084]
Method: impact assessment. Device not returned. Results: device not returned. The supplied impact assessment stated that based on the packaging and temperature requirements for the grafts, the movement of the grafts from one facility to another while maintained at room temperature for the stated time does not conflict with the labeled storage conditions. Conclusion: the investigation concluded this is a compliance issue with the proper handling process of tissue products and there is no device specific failure mode with the reported device. Implanted.
Patient Sequence No: 1, Text Type: N, H10
[52783105]
It was reported that: protocol at medical center was not followed for proper transportation of bone wedge biologic graft. The representative physically brought in the graft from a different facility that had shipped in the morning of the incident. The graft should have been shipped in directly and not brought in from another facility. Update: on (b)(6) 2016; it was reported the graft was used in a patient. Furthermore, it was reported the patient is doing well and no adverse consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
[54420157]
Method: risk assessment; results: there is no device specific failure mode identified with the reported device, the issue was with proper facility transfer protocol not being followed. Conclusion: the investigation concluded this is a compliance issue with the proper handling process of tissue products and there is no device specific failure mode with the reported device.
Patient Sequence No: 1, Text Type: N, H10
[54420158]
It was reported that; protocol at medical center was not followed for proper transportation of bone wedge biologic graft. The representative physically brought in the graft from a different facility that had shipped in the morning of the incident. The graft should have been shipped in directly and not brought in from another facility. Update: on 27-jul-2016; it was reported the graft was used in a patient. Furthermore, it was reported the patient is doing well and no adverse consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2016-00324 |
| MDR Report Key | 5857780 |
| Date Received | 2016-08-09 |
| Date of Report | 2016-02-08 |
| Date of Event | 2016-01-28 |
| Date Mfgr Received | 2016-07-27 |
| Date Added to Maude | 2016-08-09 |
| 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 | MS. CHRISTA MARROW |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608000 |
| Manufacturer G1 | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Street | 45 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLOGRAFT EVANS WEDGE 10X22X20MM |
| Generic Name | RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE |
| Product Code | MBP |
| Date Received | 2016-08-09 |
| Catalog Number | 3102-1910 |
| Lot Number | 153193-1011 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-09 |