FDA Adverse Event
Malfunction
Summary report: N
#7 SCORPIO 4:1 CERAMIC BLOCKS
MDR report key: 1925108
·
Received November 23, 2010
Report
- Report Number
- 2249697-2010-01603
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- November 4, 2010
- Report Date
- November 4, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- 2249697-12/14/09-012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS: MFR # 2249697-2010-01602 AND 01604.
Description of Event or Problem · 1
IT WAS REPORTED, "AS PART OF ROUTINE INSPECTION AT THE HOSPITAL AND FOLLOWING THE INSPECTION GUIDELINES RELATING TO RA 2009-008, THE STERILE SERVICES DEPARTMENT HAVE REPORTED VIA THE SALES REP THAT 3 FURTHER BLOCKS HAVE USING THESE BLOCKS VERY FREQUENTLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | #7 SCORPIO 4:1 CERAMIC BLOCKS | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |