FDA Adverse Event Malfunction Summary report: N

MERCURY

MDR report key: 11864531 · Received May 21, 2021

Report

Report Number: 3004893332-2021-00005
Event Type: Malfunction
Date Received: May 21, 2021
Date of Event: April 23, 2021
Report Date: April 23, 2021
Manufacturer: SPINAL ELEMENTS, INC
Product Code: NKB
PMA / PMN Number: K083230
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PATIENT'S RADIOGRAPHIC IMAGING DEPICTS BILATERAL SCREW SHANK FRACTURES IN THE SACRUM. NO INTERBODIES ARE DEPICTED IN THE IMAGES. NO INTER-VERTEBRAL FUSION APPEARS TO HAVE OCCURRED AT LEVELS TREATED AND THE DEGREE OF POSTEROLATERAL PSEUDARTHROSIS IS UNKNOWN. THE DEVICES WERE NOT RETURNED TO CARLSBAD AS THEY REMAIN IN-SITU AND THEREFORE COULD NOT BE EVALUATED. THE DURATION TO FAILURE (POSSIBLY 10 YEARS FOLLOWING SURGERY) MAYBE A CONTRIBUTING FACTOR. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY, STRESS AND FORCES EFFECTING THE LONGEVITY OF THE DEVICE, THE DEGREE OF POST LATERAL PSEUDARTHROSIS 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 OR SPECIFIC FAILURE MODE CANNOT BE DETERMINED.

Description of Event or Problem · 1

ON (B)(6) 2021, RADIOGRAPHS WERE RECEIVED DEPICTING A BILATERAL SCREW FRACTURE AT S1. THE PATIENT IS UNDERGOING EVALUATION BY PHYSICIAN IN (B)(6), THOUGH INITIAL SURGERY REPORTEDLY OCCURRED IN (B)(6) IN 2011. MEDICAL RECORDS COULD NOT BE PROVIDED. NO OTHER EVENT INFORMATION WAS PROVIDED. REVISION WAS SCHEDULED AND THEN POSTPONED. PLANNED REVISION DATE IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
760040	MERCURY	THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM	NKB	SPINAL ELEMENTS, INC

Patients

Seq	Age	Sex	Outcome	Treatment
1