Catalog Number 5401-85500 |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
Bone Fracture(s) (1870)
|
Event Date 10/11/2016 |
Event Type
malfunction
|
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
|
On 10/19/2016 it was reported to k2m, inc.That a surgery took place in which a nile clamp was implanted and explanted multiple times due to motor signal loss.Lamina fracture was noticed at the level of issue.Surgery took place (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.The reported difficulty in inserting the set screw was likely caused by the clamp being implanted and explanted multiple times.The fractured lamina of the patient was likely caused by the multiple attempts of tensioning and loosening the clamp on the lamina.Our investigation of the product and review of the manufacturing and inspection records revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends.
|
|
Event Description
|
On 10/19/2016 it was reported to k2m, inc.That a surgery took place in which a nile clamp was implanted and explanted multiple times due to motor signal loss.Lamina fracture was noticed at the level of issue.After repeated removals and replacement there was difficulty inserting one of the set screws.Surgery took place (b)(6) 2016.
|
|
Search Alerts/Recalls
|