FDA Adverse Event Injury Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 10365839 · Received August 4, 2020

Report

Report Number: 1030489-2020-01031
Event Type: Injury
Date Received: August 4, 2020
Report Date: August 4, 2020
Manufacturer: WARSAW ORTHOPEDICS
Product Code: KWP
PMA / PMN Number: SEE H10
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

SIMILAR PRODUCT WITH PRODUCT# 8699120 AND 510(K)# - K981676 IS MARKETED IN US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT OF THORACIC SPINE. IT WAS REPORTED THAT REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020 FOR EXTENDING THE FIXATION TO UPPER LEVEL. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-JUL-17: FUSION FOR EXTENDING FROM T7 TO L2 WAS PERFORMED FOR THE PATIENT WHO WAS PERFORMED FIXATION AT TH1-5. ROD CONNECTION WAS PERFORMED BY MRC VERTICAL CONNECTION NEAR T6. PATIENT HAD OSSIFICATION. THE PRODUCT NUMBER WAS G8699120 AND LOT NUMBER WAS W08F3994. .

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
830068	CD HORIZON SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	G8699120	W08F3994

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention