MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-23 for UNKNOWN BIOMET SCREW N/A UNKNOWN BIOMET SCREW manufactured by Biomet 3i.
[142796110]
This report is being submitted to report (b)(4).. Concomitant medical products: full osseotite? Tapered certain? Implant 4 x 10mm: item #: ifnt410, lot #: 2015091451. The following information is unknown at the time of this report: patient identifier: not provided. Age or date of birth: date of birth not provided. Weight: not provided. Ethnicity: not provided. Procode: product code unknown. The device is expected for evaluation, but has not yet been received. Once investigation is complete, a follow up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[142796111]
It was reported that the gold screw broke in the implant at tooth location 7. The dr was unable to retrieve the broken screw from implant. The implant was removed. There was no report of patient injury. The patient will not return to have implant replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2019-00352 |
| MDR Report Key | 8540129 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-23 |
| Date of Report | 2019-07-03 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2019-07-03 |
| Date Added to Maude | 2019-04-23 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN BIOMET SCREW |
| Generic Name | RESTORATIVE SCREW |
| Product Code | DZL |
| Date Received | 2019-04-23 |
| Model Number | N/A |
| Catalog Number | UNKNOWN BIOMET SCREW |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2019-04-23 |