MAUDE Adverse Event Report: K2M. INC CASPIAN SPINAL SYSTEMS; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 1101-90116

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/12/2018

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a surgery took place in which a torque limiting handle did not function as intended.During washout, it was discovered that set screws had become loose.Patient was revised (b)(6) 2018.(related to 3004774118-00138).

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The instruments were returned, visually and functionally inspected.Upon functional testing of the handle, it was observed that the handle consistently produces 2 nm of force, and therefore functions as intended.This incident could not be replicated and no root cause could be determined.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a surgery took place in which a torque limiting handle did not function as intended.During washout, it was discovered that a set screw had losened.Patient was revised (b)(6) 2018.(related to 3004774118-2018-00138 and 3004774118-2018-00140).

• Brand Name: CASPIAN SPINAL SYSTEMS
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 7860528
• MDR Text Key: 119702426
• Report Number: 3004774118-2018-00139
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1101-90116
• Device Lot Number: FEYY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7601-10001 LOT UNKNOWN; 7601-90103 LOT GBAF; 7601-90103 LOT UNKNOWN, 7601-10001 LOT UNKNOWN,; 7601-90103 LOT UNKNOWN, 7601-10001 LOT UNKNOWN,
• Patient Outcome(s): Required Intervention