FDA Adverse Event
Malfunction
Summary report: N
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L38
MDR report key: 7946595
·
Received October 9, 2018
Report
- Report Number
- 3005180920-2018-00783
- Event Type
- Malfunction
- Date Received
- October 9, 2018
- Date of Event
- September 13, 2018
- Report Date
- October 9, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- PHX
- UDI-DI
- 07630040706506
- PMA / PMN Number
- K170452
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 09 OCTOBER 2018 LOT 172585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 2017. EXPIRATION DATE: 2022-10-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
WHILE PERFORMING THE FINAL TIGHTENING OF THE SCREW, THE HEAD OF THE INNER SCREW BROKE OFF. THE SURGEON WAS ABLE TO RECOVER IT. THE SURGERY WAS COMPLETED SUCCESSFULLY AND WITHOUT DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 786883 | REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L38 | GLENOID POLYAXIAL LOCKING SCREW | PHX | MEDACTA INTERNATIONAL SA | 174286 | 07630040706506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |