FDA Adverse Event Malfunction Summary report: N

ATOLL CERVICO-THORACIC SYSTEM

MDR report key: 11822235 · Received May 13, 2021

Report

Report Number: 3012120772-2021-00042
Event Type: Malfunction
Date Received: May 13, 2021
Date of Event: March 24, 2021
Report Date: May 13, 2021
Manufacturer: SEASPINE ORTHOPEDICS CORPORATION
Product Code: KWP
UDI-DI: 10889981052348
PMA / PMN Number: K083073
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

VISUAL INSPECTION OF THE RETURNED 16-12-3514 3.5MM X 14MM POLYAXIAL SCREW CONFIRMED THE SHANK SHEARED OFF AROUND THE 2ND FULL TURN OF THE EXPOSED THREAD; THE FAILURE OCCURRED HORIZONTALLY THROUGH THE CYLINDER. NONE OF THE OTHER RETURNED SCREW ASSEMBLY COMPONENTS WERE OBSERVED TO BE DAMAGED. THE INFORMATION PROVIDED AND INSPECTION OF THE RETURNED SCREW SUGGEST EXCESSIVE FORCE WAS LIKELY PLACED ON THE INSTRUMENTATION AND SCREW AT THE TIME OF INSERTION DUE TO RESISTANCE FROM THE PATIENT'S HARD BONE, RESULTING IN THE FRACTURE OBSERVED. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS- BENDING, DISASSEMBLY OR FRACTURE OF IMPLANT AND COMPONENTS.

Description of Event or Problem · 1

A PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2021 CONSISTING OF SEASPINE'S ATOLL PEDICLE FIXATION SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD VERY HARD BONE AND A SCREW FRACTURED UPON INSERTION INTO THE LATERAL MASS. THE SURGEON ELECTED TO LEAVE A PORTION OF THE SCREW IN THE PATIENT. ADDITIONALLY, THERE WAS NO PATIENT HARM OR INJURY AND NO INDICATION NECESSITATING MEDICAL OR SURGICAL INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
715521	ATOLL CERVICO-THORACIC SYSTEM	3.5MM X 14MM POLY SCREW ASSM	KWP	SEASPINE ORTHOPEDICS CORPORATION	16-12-3514	BR38067R	10889981052348

Patients

Seq	Age	Sex	Outcome	Treatment
1