Catalog Number 801-06545 |
Device Problem
Disassembly (1168)
|
Patient Problem
No Information (3190)
|
Event Date 12/03/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.
|
|
Event Description
|
It was reported to k2m, inc.On 12.06.2016 that the outer collet of a screw broke during rod reduction and had to be removed and replaced, causing a significant delay in the surgery.Surgery took place on (b)(6) 2016.
|
|
Manufacturer Narrative
|
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.There were markings on the remaining side of the inner collet consistent with use of the cricket rod reduction instrument including indications of possible instrument misalignment.The outer tulip head had deformation on one flange indicating only one contact point for the locker interface.There were no marks in the inner collet rod interface indicating the rod never nested properly.It is likely the screw was in a partial locked state prior to the attempted rod reduction and locking.The force of the rod pressing on the partial locked inner collet likely caused the collet fracture.
|
|
Event Description
|
It was reported to k2m, inc.On (b)(6) 2016 that the outer collet of a screw broke during rod reduction and had to be removed and replaced, causing a significant delay in the surgery.Surgery took place on (b)(6) 2016.
|
|
Search Alerts/Recalls
|