FDA Adverse Event Injury Summary report: N

CRESCENT SPINAL SYSTEM

MDR report key: 5401164 · Received February 1, 2016

Report

Report Number: 1030489-2016-00347
Event Type: Injury
Date Received: February 1, 2016
Date of Event: January 6, 2016
Report Date: January 6, 2016
Manufacturer: MSD DEGGENDORF MFG
Product Code: MAX
PMA / PMN Number: SEE H10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9393011, 510K # K094025 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT PLIF SURGERY AT L3-L5 FOR LUMBAR SPONDYLOLISTHESIS.THE SURGEON TRIED TO INSERT A CAGE AFTER RODS PLACEMENT. INSERTER WAS TILTED TO A MAXIMUM FOR THE INSERTION. THE CAGE WAS ROTATED AT THE ANTERIOR PART BUT IT WAS SUSPECTED ON AN INTRAOPERATIVE LATERAL IMAGE THAT THE MARKER ON THE CAGE WAS PROTRUDED TO ANTERIOR EDGE OF THE VERTEBRAL BODY. THE SURGEON REMOVED A ROD OF THE APPROACH SIDE AND PULLED A CAGE BACK WITH AN ADJUSTER. THE CAGE WAS ROTATED AGAIN AT THE CENTER OF THE VERTEBRAL BODY. THE SURGERY WAS COMPLETED AFTER COMPRESSION AND PLACEMENT OF CROSS LINK.THE SURGEON SUSPECTED "ALL" RUPTURE.THE SURGERY WAS EXTENDED FOR 16-30 MINS. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
61044	CRESCENT SPINAL SYSTEM	INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR	MAX	MSD DEGGENDORF MFG	NA	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	00078 YR		Other