MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-02 for 3S HEMI IMPLANT, SMALL, NON-STERILE 101-00-001 manufactured by Trilliant Surgical.
[126067938]
The event is regarding a 3s hemi small implant originally implanted in 2013 that malfunctioned. The implant was noted by the patient in (b)(6) 2017 to have become visible on the dorsal aspect of the surgical site. As a result, the surgeon reviewed the implant in (b)(6) 2018, noted the implant was in excellent placement, yet removed it in (b)(6) 2018. The surgeon noted there is a hole present on the dorsal aspect of the bone, post removal. There is no information regarding an additional surgery to correct any bone interference at this time. The complaint was confirmed by review of the provided x-ray. As discussed in the surgical technique review section, there are several contributing factors that could have resulted in the reported event; however, none can be definitively determined due to limited details provided. Review of the complaint log revealed one other similar event. Based on the above investigation, no other actions is deemed necessary at this time. If additional details that would impact the conclusion of this report are reported to trilliant surgical, a supplemental report shall be submitted within the defined timeframe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420745-2018-00017 |
| MDR Report Key | 8035493 |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-10-05 |
| Date Added to Maude | 2018-11-02 |
| 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. JODIE RODRIGUEZ |
| Manufacturer Street | 727 N SHEPHERD DR SUITE 100 |
| Manufacturer City | HOUSTON TX 77007 |
| Manufacturer Country | US |
| Manufacturer Postal | 77007 |
| Manufacturer Phone | 8004952919 |
| Manufacturer G1 | TRILLIANT SURGICAL |
| Manufacturer Street | 727 N SHEPHERD DR SUITE 100 |
| Manufacturer City | HOUSTON TX 77007 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77007 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3S HEMI IMPLANT, SMALL, NON-STERILE |
| Generic Name | 3S HEMI IMPLANT, SMALL, NON-STERILE |
| Product Code | KWD |
| Date Received | 2018-11-02 |
| Returned To Mfg | 2018-10-10 |
| Model Number | 101-00-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRILLIANT SURGICAL |
| Manufacturer Address | 727 N SHEPHERD DR SUITE 100 HOUSTON 77007 US 77007 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-02 |