FDA Adverse Event
Injury
Summary report: N
DXTEND GLENOSPHERE STD D38MM
MDR report key: 7464394
·
Received April 26, 2018
Report
- Report Number
- 1818910-2018-58316
- Event Type
- Injury
- Date Received
- April 26, 2018
- Date of Event
- April 1, 2018
- Report Date
- April 1, 2018
- Manufacturer
- FRA
- Product Code
- HSD
- UDI-DI
- 10603295027768
- PMA / PMN Number
- K062250
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative · 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2018; DOR: (B)(6) 2018 RIGHT SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307100 | DXTEND GLENOSPHERE STD D38MM | DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE | HSD | FRA | 5307066 | 10603295027768 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |