MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 801-06545

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 03/18/2020

Event Type  Injury  

Event Description

It was reported that two mesa polyaxial screws fractured post-operatively.The patient was revised.This report represents the second of the two screws.

Manufacturer Narrative

Functional, dimensional, and material analysis could not be performed as the device was not available.However, x-rays were provided by the rep.Upon review, it was observed that bilateral screws, implanted at the most caudal level of a construct, broke approximately mid-shaft.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.The mesa degenerative surgical technique was reviewed and the following relevant information was identified: internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.Non-union may have contributed to the failure, as the patient did not fuse.However, as no devices were available for evaluation, the root cause could not be determined conclusively.H3 other text : status and location of the device is unknown.

Event Description

It was reported that two mesa polyaxial screws fractured post-operatively.The patient was revised.This report represents the second of the two screws.

• Brand Name: POLYAXIAL SCREW; SIZE 6.5X45 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9960467
• MDR Text Key: 187952887
• Report Number: 3004774118-2020-00069
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857136168
• UDI-Public: 10888857136168
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 801-06545
• Device Catalogue Number: 801-06545
• Device Lot Number: JKEF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention