FDA Adverse Event
Malfunction
Summary report: N
OSTEONIC UNIV. DISTAL SPACER
MDR report key: 1650898
·
Received March 30, 2010
Report
- Report Number
- 2249697-2010-00345
- Event Type
- Malfunction
- Date Received
- March 30, 2010
- Date of Event
- March 9, 2010
- Report Date
- March 10, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LZN
- PMA / PMN Number
- K992462
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "SURGEON PLACED CENTRALIZER ON EON STEM. GENTLY IMPACTED WITH MALLER. ONE "FIN" BROKE OFF CENTRALIZER. SURGEON FELT WITH HAND AND ENTIRE PIECE BROKE OFF. SURGEON WAS UNABLE TO PUT ON A NEW CENTRALIZER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEONIC UNIV. DISTAL SPACER | IMPLANT | LZN | STRYKER ORTHOPAEDICS MAHWAH | NA | R78MHD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |