MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for SCREW manufactured by Biomet 3i.
[138096635]
(b)(4). Patient's identifier unknown/ not provided. Patient's age unknown/ not provided. Patient's weight unknown/ not provided. Date of the event unknown. Device brand name unknown. Device product code unknown. 510(k) number unknown. Product not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[138096636]
It was reported that the unknown biomet screw fractured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2019-00155 |
| MDR Report Key | 8378973 |
| Date Received | 2019-02-28 |
| Date of Report | 2019-06-05 |
| Date Mfgr Received | 2019-06-04 |
| Date Added to Maude | 2019-02-28 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SUSANNE TAYLOR |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5617766700 |
| Manufacturer G1 | BIOMET 3I |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | SCREW |
| Product Code | DZL |
| Date Received | 2019-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET 3I |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-28 |