MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-19 for SPECTRA-SYSTEM/ LEGACY GUIDED SURGERY HANDLE KIT G-HK manufactured by Implant Direct Sybron Manufacturing Llc.
[180153539]
Per complaint (b)(4), surgical guide handle is apparently warped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001617766-2020-01727 |
| MDR Report Key | 9725527 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2014-06-10 |
| Date Added to Maude | 2020-02-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | SPECTRA-SYSTEM/ LEGACY GUIDED SURGERY HANDLE KIT |
| Generic Name | DENTAL IMPLANT |
| Product Code | NDP |
| Date Received | 2020-02-19 |
| Model Number | G-HK |
| Catalog Number | G-HK |
| Lot Number | 52360 |
| Device Expiration Date | 2019-06-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-19 |