FDA Adverse Event Injury Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 9289110 · Received November 7, 2019

Report

Report Number: 1030489-2019-01286
Event Type: Injury
Date Received: November 7, 2019
Report Date: November 7, 2019
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: KWP
PMA / PMN Number: SEE H10
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

OTHER: ALLERGIC REACTION, DISABLING PAIN, EXTREME SWELLING, NERVE PAIN: THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 54840046535, LOT# UNK, UDI: (B)(4), 510K: K141494 2. PRODUCT ID: 5440030, LOT# UNK, UDI: (B)(4), 510K: K102555. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL FUSION SURGERY DUE TO SOME UNKNOWN REASONS. POST-OP, PATIENT WIFE REPORTED VIA A PHONE CALL THAT HER HUSBAND THINKS THAT HE IS SUFFERING WITH ALLERGIC REACTION, DISABLING PAIN, EXTREME SWELLING, NERVE PAIN. NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1083586	CD HORIZON SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MEDTRONIC SOFAMOR DANEK USA, INC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other