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 SWISH TITANIUM NON-ENGAGING TEMPORARY ABUT. 9048-49 manufactured by Implant Direct Sybron Manufacturing Llc.
[186541128]
This complaint was identified internally and generated for ncmr 10279. Per the ncmr, the part will be destroyed.
Patient Sequence No: 1, Text Type: N, H10
[186541129]
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 | 3001617766-2020-02949 |
| MDR Report Key | 9873302 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-08-02 |
| Date Mfgr Received | 2019-08-02 |
| Device Manufacturer Date | 2019-05-13 |
| 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 | SWISH TITANIUM NON-ENGAGING TEMPORARY ABUT. |
| Generic Name | DENTAL IMPLANT |
| Product Code | NHA |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2019-08-02 |
| Model Number | 9048-49 |
| Catalog Number | 9048-49 |
| Lot Number | 142088 |
| 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 |