FDA Adverse Event
Malfunction
Summary report: N
KERRISON DET130 DEG UP 1MM 180MMTHP
MDR report key: 3234477
·
Received July 3, 2013
Report
- Report Number
- 2916714-2013-00073
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- April 12, 2013
- Report Date
- June 27, 2013
- Manufacturer
- AESCULAP AG & CO. KG
- Product Code
- GXJ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL: THE INSTRUMENT WAS MICROSCOPICALLY CHECKED. THE BREAKAGE AREA OF THE BROKEN FOOT PLATE FOLLOWED A PATTERN KNOWN AS "TRANSCRYSTALLINE FORCE FRACTURE". THE DIRECTION OF BREAKAGE IS TO THE RIGHT FRONT. ANY HINTS FOR A MATERIAL OR MFG ISSUE COULD NOT BE FOUND. BASED ON THE INVESTIGATION RESULTS, THIS ISSUE IS LIKELY RELATED TO HANDLING INFLUENCES.
Description of Event or Problem · 1
KERRISON BROKE OFF AT TIP DURING ACDF. TIP WAS FOUND IN PT. NO PT INJURY OR PROLONGING OF SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303570 | KERRISON DET130 DEG UP 1MM 180MMTHP | GXJ | AESCULAP AG & CO. KG | FK906R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |