ZEPHIR

Report

Report Number: 1030489-2013-01705
Event Type: Injury
Date Received: May 15, 2013
Date of Event: April 17, 2013
Report Date: April 17, 2013
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: KWQ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8799132, 510K # K994239 WAS CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G8799132 / LOT: UNKNOWN PART: G8792113 / LOT: UNKNOWN. ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL PROCEDURE AT C6-C7 TO TREAT CERVICAL DISC HERNIATION. IT WAS REPORTED THAT IMMEDIATELY POST-OP, "THE PATIENT LEFT LEG WAS PARALYZED. A REVISION SURGERY WAS PERFORMED. THE SURGEON REMOVED THE AUTOGRAFT FROM THE PATIENT AND RE-INSERTED IT IN THE PATIENT AFTER THE SURGEON MAKE THE AUTOGRAFT SMALLER, BUT THE PATIENT SYMPTOM WAS STILL THE SAME. AS A RESULT, A LAMINOPLASTY WAS PERFORMED VIA POSTERIOR APPROACH. THE SURGEON COMMENTED THAT THE SIZE OF THE AUTOGRAFT MIGHT HAVE BEEN TOO BIG." ACCORDING TO THE REPORT, IT WAS SUSPECTED THAT THE PATIENT'S NERVE MAY HAVE BEEN DAMAGED DURING THE DECOMPRESSION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
214052	ZEPHIR	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	SELF-TAPPING CERVICAL SCREWS, AUTOGRAFT