FDA Adverse Event
Injury
Summary report: N
SECUR-FIT PLUS-MAX
MDR report key: 2347367
·
Received November 16, 2011
Report
- Report Number
- 2249697-2011-01623
- Event Type
- Injury
- Date Received
- November 16, 2011
- Date of Event
- October 24, 2011
- Report Date
- October 24, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LZO
- PMA / PMN Number
- K041170
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 06-2800, LOT # MKA7P4, DESCRIPTION: C-TAPER COCR LFIT HEAD 28MM/0. CAT # UH1-55-28, LOT# MKHWTR, DESCRIPTION: UHR BIPOLAR 28X55MM.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT FELL AND BROKE TROCH."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECUR-FIT PLUS-MAX | IMPLANT | LZO | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other| R |