MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for BONE GRAFT HARVESTING SYSTEM manufactured by Acumed Llc.
[105901472]
For spinal fusion surgery, a bone graft harvesting system was used to harvest bone from the iliac crest. Patient having pain 1-3 months following surgery at the site of the harvest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3025141-2018-00173 |
| MDR Report Key | 7428248 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-03 |
| Date Mfgr Received | 2018-04-03 |
| Date Added to Maude | 2018-04-13 |
| 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. MICKI LEHMAN |
| Manufacturer Street | 5885 NE CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 97124 |
| Manufacturer Country | US |
| Manufacturer Postal | 97124 |
| Manufacturer Phone | 8886279957 |
| Manufacturer G1 | ACUMED LLC |
| Manufacturer Street | 5885 NE CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 97124 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONE GRAFT HARVESTING SYSTEM |
| Generic Name | BIT, DRILL |
| Product Code | KIJ |
| Date Received | 2018-04-13 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACUMED LLC |
| Manufacturer Address | 5885 NE CORNELIUS PASS ROAD HILLSBORO OR 97124 US 97124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |