FDA Adverse Event
Malfunction
Summary report: N
#7 SCORPIO 4:1 CERAMIC BLOCKS
MDR report key: 1925111
·
Received November 23, 2010
Report
- Report Number
- 2249697-2010-01606
- 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 # 2249697-2010-01605, 01607, 01608.
Description of Event or Problem · 1
IT WAS REPORTED, "AS PART OF THE ROUTINE INSPECTION ACCORDING TO THE GUIDELINES IN (B)(4), THE STERILE SERVICES MANAGER REPORTED VIA THE SALES REP THAT 10 CUTTING BLOCKS HAD FAILED INSPECTION AND THEY WERE ALL MISSING CERAMIC RAILS". THREE DEVICES CATALOG # 8000-0007 (UNK LOT#) WERE REPORTED.
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 | Other |