XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
Received Nov 23, 2015 · Event occurred Oct 30, 2015
Report 3005525032-2015-00136 · MDR key 5243450
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Stryker Spine-switzerlandCatalog number
48232601
Lot number
M8V
Product problems
- Break
- Material Integrity Problem
Patient
Not reported
- Injury
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
LOT# M8V. METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE RETURNED ROD WAS CONFIRMED TO HAVE FRACTURED AT THE LASER MARKING DOT. THE LASER MARKING DOT WAS INSPECTED USING A MICROSCOPE AND VOIDS WERE IDENTIFIED. THESE VOIDS CAN ACT AS STRESS RISERS WHEN PLACED ON THE TENSILE SIDE OF THE BEND, WHICH THEY WERE IN THIS CASE. CONCLUSION: THE MOST LIKELY CAUSE OF THE CUSTOMER REPORTED EVENT IS THE PRESENCE OF VOIDS ON THE LASER MARKING DOT, AS A RESULT OF THE MANUFACTURING PROCESS.
Description of Event or Problem
IT WAS REPORTED THAT THE ROD BROKE UPON BENDING.
Description of Event or Problem
IT WAS REPORTED THAT THE ROD BROKE UPON BENDING.