|Catalog Number 487.356|
|Event Date 10/25/2012|
(b)(4): a device history record review was conducted.
Mrrs nonconformance associated with the part are not relevant to the complaint condition.
No other discrepancies were noted that would be associated with this complaint.
A manufacturing evaluation was conducted.
The plate was received with anodize discoloration and nicks/scratches on top and bottom of part and nicks/scratches in d2 holes.
Bone in-growth is visible on the screw included in the bag with the plate.
All described nonconformities are post manufacturing.
All readings for the raw material were acceptable.
The cslp plate performed as designed, patient fused with good outcome.
Device was used for treatment.
The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.
Without a lot number the device history records review could not be completed.
Patient was implanted with ti cervical spine locking plate and screws to the cervical spine at c4-c7 on (b)(6) 2010.
The patient returned for a routine follow-up and x-rays were taken.
The surgeon noticed two of the cslp screws were broken.
Reportedly one screw was broken mid shaft and the other screw was broken a few threads below the head of the screw.
The surgeon decided to remove all of the hardware.
Patient was returned to the operating room on (b)(6) 2012, for removal of one plate and sixteen screws.
Patient was not revised with any additional hardware as the patient was fused and the surgeon was satisfied with the outcome.
The procedure was completed successfully.
This is 3 of 3 reports for the same event.
Device used for treatment and not diagnosis.
Based on the information provided, it will not be possible to determine what the cause of the malfunction was.
The breakage likely happened before the patient fused, but there is nothing that indicates the design contributed to it.
There may have been some excessive strain by the patient or other excessive forces on the construct.
The design risk assessment is adequate for the intended use.