FDA Adverse Event Injury Summary report: N

VENTURE ANTERIOR CERVICAL PLATE SYSTEM

MDR report key: 6338512 · Received February 17, 2017

Report

Report Number: 1030489-2017-00326
Event Type: Injury
Date Received: February 17, 2017
Report Date: January 23, 2017
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
Product Code: KWQ
PMA / PMN Number: REFER H10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

G5: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG# 9795213 AND 510K# K042922 AND (B)(4) OF THE 'LIKE DEVICE' WAS CLEARED IN THE UNITED STATES. 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.

Additional Manufacturer Narrative · 1

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: CERVICAL DISC HERNIATION. FOR WHICH PATIENT UNDERWENT PATIENT UNDERWENT CERVICAL ANTERIOR FUSION AT LEVELS C4-C5. INTRA-OP, X-RAY REVEALED THAT A SCREW AT CAUDAL SIDE PENETRATED THE LOWER END PLATE. THERE WAS A DELAY OF MORE THAN 60 MIN DUE TO THIS EVENT. THE SURGEON RE-INSERTED THE SCREW AFTER KNOWING ABOUT THE DEVIATION BUT THE SCREW WENT TO SAME DIRECTION. PATIENT COMPLICATIONS WERE UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
121133	VENTURE ANTERIOR CERVICAL PLATE SYSTEM	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	MDT SOFAMOR DANEK PUERTO RICO MFG	NA	H09L7390

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other