FDA Adverse Event Malfunction Summary report: N

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

MDR report key: 4756867 · Received May 7, 2015

Report

Report Number: 1030489-2015-00932
Event Type: Malfunction
Date Received: May 7, 2015
Date of Event: April 8, 2015
Report Date: April 8, 2015
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: KWP
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # 6860162 AND 510K # K992110 OF A 'LIKE DEVICE' WAS CLEARED IN THE UNITED STATES.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION WITH DECOMPRESSION AT C4 TO C7 TO TREAT OPLL (OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT) WITH SUBTOTAL VERTEBRECTOMY PERFORMED AT C5 AND C6. DURING THE SURGERY, WHEN THE SLIDING WASHER OF A CERVICAL PLATE WAS SET TO THE ¿LOCKED¿ POSITION, THE SLIDING WASHER COULD NOT BE FULLY POSITIONED INTO THE LOCKED POSITION. ALL SCREWS WERE TIGHTENED AS MUCH AS POSSIBLE UNTIL THE SCREW JUST SPUN AROUND DUE TO SUSPECTED INCOMPLETE SCREW INSERTION. THIS EXCESSIVE SCREW TIGHTENING MIGHT HAVE HAD A NEGATIVE EFFECT ON SCREW STABILITY. THE SURGERY WAS COMPLETED WITHOUT COMPLETE LOCKING. AS A RESULT OF THE INCIDENT, THE SURGICAL TIME WAS EXTENDED BY 16 TO 30 MINUTES. THE PHYSICIAN COMMENTED THAT A NARROW SPACE BETWEEN A SLIDING WASHER AND THE PLATE ITSELF COULD BE A POSSIBLE CONTRIBUTING FACTOR FOR THE INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
299905	PREMIER® ANTERIOR CERVICAL PLATE SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1				SCREWS