FDA Adverse Event
Malfunction
Summary report: N
ESCALATE EXPANDABLE PLATE
MDR report key: 3756903
·
Received April 17, 2014
Report
- Report Number
- 0009617544-2014-00170
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 31, 2014
- Report Date
- March 31, 2014
- Manufacturer
- STRYKER SPINE-FRANCE
- Product Code
- NQW
- PMA / PMN Number
- K113802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: MECHANICAL EVALUATION. RESULTS: THE RETURNED PART WAS ABLE TO BE REASSEMBLED AND EXPANDED AND CONTRACTED AS PER DESIGN. THE SURGICAL THERE WAS NO ISSUE FOUND WITH THE RETURNED DEVICE. CONCLUSION: THE RETURNED ESCALATE EXPANDABLE PLATE WAS NOT CONFIRMED TO HAVE FRACTURED. MANUFACTURING FILES WERE REVIEWED AND NO ISSUES WERE FOUND. THE REPORTED EVENT RESULTED IN A 3 MINUTE DELAY IN SURGERY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE EXPANDABLE PLATE BROKE INTO TWO PIECES WHILE EXPANDING.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE EXPANDABLE PLATE BROKE INTO TWO PIECES WHILE EXPANDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235592 | ESCALATE EXPANDABLE PLATE | IMPLANT-CERVICAL PLATE | NQW | STRYKER SPINE-FRANCE | 139898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |