MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-12-18 for STABLELOC EXTERNAL FIXATOR KIT FX-4001-S manufactured by Acumed Llc.
[183714486]
The stableloc external fixator assembly (pn:fx-4000 /batch#467981) was inspected upon its return. Even upon removal of the set screw, the ball joint is not able to freely rotate. The examination of the ball joint showed damage to the anodization layer of the ball joint. Lost material may become stuck in the joint housing prohibit full range of motion.
Patient Sequence No: 1, Text Type: N, H10
[183714487]
While using a stableloc external fixator kit, the spherical joint failed and the device could not be used. As a result of this issue, there was a 15 minute delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3025141-2019-00635 |
| MDR Report Key | 9489876 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-12-18 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-11-23 |
| Date Mfgr Received | 2019-11-25 |
| Device Manufacturer Date | 2019-06-14 |
| Date Added to Maude | 2019-12-18 |
| 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 ANDERSON |
| 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 | 3 |
| Brand Name | STABLELOC EXTERNAL FIXATOR KIT |
| Generic Name | COMPONENT, TRACTION, INVASIVE: STABLELOC |
| Product Code | JEC |
| Date Received | 2019-12-18 |
| Returned To Mfg | 2019-12-09 |
| Model Number | FX-4001-S |
| Catalog Number | FX-4001-S |
| Lot Number | 470155 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-12-18 |