MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-24 for LEGACY SMARTBASE, NARROW 8735-80N manufactured by Implant Direct Sybron Manufacturing Llc.
[184735252]
This complaint is also for lot 130577 with manufacture date 12/19/2018 and expiration date 12/18/2023. This complaint was identified internally and generated for ncmr (b)(4). Per the ncmr, the part will be destroyed.
Patient Sequence No: 1, Text Type: N, H10
[184735253]
Per complaint (b)(4), during an internal review, a part was identified as missing a label.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001617766-2020-02954 |
| MDR Report Key | 9873308 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-09-04 |
| Date Mfgr Received | 2019-09-04 |
| Device Manufacturer Date | 2019-05-08 |
| Date Added to Maude | 2020-03-24 |
| 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 ADRIENNE STOTT |
| Manufacturer Street | 3050 EAST HILLCREST DRIVE |
| Manufacturer City | THOUSAND OAKS, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4443300357 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGACY SMARTBASE, NARROW |
| Generic Name | DENTAL IMPLANT |
| Product Code | NHA |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2019-09-04 |
| Catalog Number | 8735-80N |
| Lot Number | 139553 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Manufacturer Address | 3050 EAST HILLCREST DRIVE THOUSAND OAKS, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |