REGENT

Report

Report Number: 1067095-2018-00003
Event Type: Malfunction
Date Received: June 18, 2018
Date of Event: January 10, 2018
Report Date: January 11, 2018
Manufacturer: SPINAL ELEMENTS
Product Code: KWQ
UDI-DI: 00840916115517
PMA / PMN Number: K101151
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NO RADIOGRAPHS OR IMAGES WERE PROVIDED, CONFIRMING THE EVENT. NO PRODUCT WAS RETURNED, NO PRODUCT INFORMATION WAS GIVEN, AND NO FURTHER EVALUATION OF THE PRODUCT CAN BE COMPLETED AT THIS TIME. PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY, PATIENT COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS, OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT ARE ALL UNKNOWN. THE FAILURE COULD NOT BE CONFIRMED AND THE ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF LABELING NOTES; CONTRAINDICATIONS: ANY ABNORMALITY PRESENT WHICH AFFECTS THE NORMAL PROCESS OF BONE REMODELING INCLUDING, BUT NOT LIMITED TO, SEVERE OSTEOPOROSIS INVOLVING THE SPINE, ACTIVE INFECTION AT THE SITE OR CERTAIN METABOLIC DISORDERS AFFECTING OSTEOGENESIS. INSUFFICIENT QUALITY OR QUANTITY OF BONE WHICH WOULD INHIBIT RIGID DEVICE FIXATION. ADVERSE EFFECTS LOOSENING OF THE IMPLANT. SCREW BACK-OUT POSSIBLY LEADING TO ESOPHAGEAL EROSION IMPLANT LOOSING OR REOPERATION FOR DEVICE REMOVAL.

Description of Event or Problem · 1

REPORTEDLY THE INITIAL TWO LEVEL ACDF SURGERY WAS PERFORMED ON (B)(6) 2017. ON (B)(6) 2018 ALLEGEDLY ONE OF THE SIX SCREWS BACKED OUT OF THE PLATE. REVISION SURGERY OCCURRED TO REMOVE AND REPLACE ONE SCREW. HOSPITAL RETAINED THE SCREW. NO FURTHER INFORMATION PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
451035	REGENT	ANTERIOR CERVICAL PLATE SCREW	KWQ	SPINAL ELEMENTS	084814		00840916115517

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention