MAUDE Adverse Event Report: MDT KYPHON SUNNYVALE MFG X-STOP PEEK INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Catalog Number 1-3210

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 09/12/2012

Event Type  malfunction  

Event Description

It was reported that a patient underwent an interspinous decompression implantation at l4/5.The patient was discharged 5 weeks post-op.At 4 weeks post-op, "an x-ray found that the space between spinous processes at the treated levels was not maintained".X-ray findings from 6 months and 12 months post op remained unchanged.No further information was reported.

Manufacturer Narrative

(b)(4): 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.

Event Description

On an unknown date in (b)(6) 2012, postoperative recurrence of pain developed.The patient¿s pain remained even after the surgery.The event was considered severe because a nerve block was performed for pain management.The event outcome was reported to be resolving on (b)(6) 2012.On an unknown date in (b)(6) 2013, l3 vertebral body fracture was found at another hospital.For the treatment of the event, no additional surgery was performed.The event was non-serious.The event outcome was not provided.The patient required no surgical intervention but was receiving the treatment (unspecified) at the time of reporting.The physician considered that the event was due to the patient-specific factor and was not causally related to the implant.It was also reported that the pain improved with a nerve block injection.

Event Description

It was confirmed that the patient received a nerve block injection six days post-op.Further details are unknown at this time.

Manufacturer Narrative

(b)(4).

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MDT KYPHON SUNNYVALE MFG; 1221 crossman ave.; sunnyvale CA 94089
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3626442
• MDR Text Key: 4135881
• Report Number: 2953769-2014-00020
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2013
• Device Catalogue Number: 1-3210
• Device Lot Number: 2245341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00078 YR