FDA Adverse Event
Malfunction
Summary report: N
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22
MDR report key: 15208238
·
Received August 11, 2022
Report
- Report Number
- 3005180920-2022-00600
- Event Type
- Malfunction
- Date Received
- August 11, 2022
- Date of Event
- July 14, 2022
- Report Date
- August 11, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- PHX
- UDI-DI
- 07630040706469
- PMA / PMN Number
- K170452
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 28 JULY 2022 LOT 2118698: LOT 2118698: (B)(4). ADDITIONAL COMPONENTS IMPLANTED: BATCH REVIEW PERFORMED ON 28 JULY 2022 REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT. 2118701: LOT 2118701: (B)(4). BATCH REVIEW PERFORMED ON 28 JULY 2022 REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE Ø24.5X15 (K170452) LOT. 2117651: LOT 2117651: (B)(4).
Description of Event or Problem · 0
2 GLENOID POLYAXIAL LOCKING SCREW PRONG HEADS BROKE WHILE THE SURGEON WAS TRYING TO INSERT THEM IN THE GLENOID BASEPLATE (1X 22MM, 1X 26MM). FINALLY A GLENOID BONE FRACTURE OCCURRED AND THE SURGEON DECIDED TO SWITCH TO AN ANATOMICAL SYSTEM. THE BONE WAS VERY HARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1383111 | REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22 | SHOULDER POLYAXIAL SCREW | PHX | MEDACTA INTERNATIONAL SA | 04.01.0159 | 2118698 | 07630040706469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Required Intervention |