FDA Adverse Event
Malfunction
Summary report: N
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW L26
MDR report key: 8403057
·
Received March 8, 2019
Report
- Report Number
- 3005180920-2019-00134
- Event Type
- Malfunction
- Date Received
- March 8, 2019
- Date of Event
- February 7, 2019
- Report Date
- March 8, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- PHX
- UDI-DI
- 07630040706476
- PMA / PMN Number
- K170452
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 07 MARCH 2019: LOT 182293: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2018. EXPIRATION DATE: 2023-08-23. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: SCREW BREAKAGE DURING IMPLANTATION. THE SCREW WAS REPLACED BY A NEW ONE AND SURGERY WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCE IS EXPECTED FOR THIS EVENT.
Description of Event or Problem · 1
THE SURGEON MAY HAVE MISPLACED THE SCREW DURING SURGERY AND THE HEAD OF THE SCREW BROKE. HE DECIDED TO USE ANOTHER SCREW TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195890 | REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW L26 | SHOULDER GLENOID POLYAXIAL LOCKING SCREW | PHX | MEDACTA INTERNATIONAL SA | 182293 | 07630040706476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |