FDA Adverse Event Injury Summary report: N

CERES

MDR report key: 14777873 · Received June 22, 2022

Report

Report Number: 3004893332-2022-00010
Event Type: Injury
Date Received: June 22, 2022
Date of Event: June 7, 2022
Report Date: June 22, 2022
Manufacturer: SPINAL ELEMENTS, INC
Product Code: KWQ
UDI-DI: 00840916127343
PMA / PMN Number: K152455
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

RETURNED DEVICE WAS VISUALLY INSPECTED, FUNCTIONALLY TESTED AND THE COMPLAINT WAS CONFIRMED. THE DEVICE LEFT LOCKING MECHANISM/CAM HAD DISASSEMBLED FROM THE PLATE. THE DEVICE MEETS DIMENSIONAL SPECIFICATIONS. THE CAM IS NOT MARRED/BENT/DAMAGED FROM OVER-ROTATION OR BEING IN CONTACT WITH A PROUD SCREW. UNKNOWN FACTORS INCLUDE: IF THE LOCKING MECHANISMS WERE PROPERLY LOCKED AT TIME OF IMPLANTATION, IF THE CAM WAS DAMAGED/LOOSENED AS A RESULT OF HANDLING IN THE FIELD, PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY OR PATIENT COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT (NO TRAUMA WAS REPORTED). ROOT CAUSE IS UNKNOWN.

Description of Event or Problem · 0

ON (B)(6) 2022, PATIENT UNDERWENT ANTERIOR CERVICAL FUSION (ACDF) SURGERY WITH A THREE LEVEL ANTERIOR CERVICAL PLATE (ACP) C3-C6. DURING ROUTINE FOLLOW-UP, RADIOGRAPHS DEPICT THE LEFT C6 LOCKING MECHANISM ON THE ACP HAD DISASSOCIATED. THE BONE SCREW HAS BACKED OUT 2-3 MM. REVISION WAS PERFORMED ON JUNE 7, 2022, TO REPLACE THE PLATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
692284	CERES	ANTERIOR CERVICAL PLATE	KWQ	SPINAL ELEMENTS, INC	12-30-0348	202449	00840916127343

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR	Male	Required Intervention