MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-10 for 4WEB ANTERIOR TRUSS SYSTEM ASTS-000002 manufactured by 4web, Inc..
[188849384]
The inserter was returned to 4web and analyzed. The broken thread was confirmed. Dimensional analysis of the inserter confirmed that it met design specifications. Cause of thread breakage is unknown. If additional information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188849385]
It was reported to 4web that the tip of the alif inserter broke within the thread hole of the implant during implantation. The broken piece of the inserter remained in the implant and was not retrieved since the surgeon believed it was better to leave the implant in place than to remove it. No patient injury or death reported. Surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009189869-2020-00002 |
| MDR Report Key | 9813763 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-10 |
| 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 | MRS. UPASANA VETURI |
| Manufacturer Street | 2801 NETWORK BOULEVARD SUITE 620 |
| Manufacturer City | FRISCO, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 2857090 |
| Manufacturer G1 | 4WEB, INC. |
| Manufacturer Street | 2801 NETWORK BOULEVARD SUITE 620 |
| Manufacturer City | FRISCO, TX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4WEB ANTERIOR TRUSS SYSTEM |
| Generic Name | INTERBODY FUSION DEVICE INSERTER |
| Product Code | MAX |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-12 |
| Model Number | ASTS-000002 |
| Catalog Number | ASTS-000002 |
| Lot Number | VM14537 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 4WEB, INC. |
| Manufacturer Address | 2801 NETWORK BOULEVARD SUITE 620 FRISCO, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |