MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC X-STOP PEEK INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Catalog Number 1-3210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

It was reported that the patient was treated for lumbar spinal canal stenosis at l3-4.Post-op, patient complained of pain and worsening of zurich claudication questionnaire(zcq) score.At the two-year follow-up, the patient underwent an examination by diagnostic radiography on (b)(6) 2014 because patient complained of chronic back pain.At the three-year follow-up, worsening of zcq score was reported.No treatment or additional surgery was performed.

Event Description

It was reported that on (b)(6) 2015, x-ray examination was performed for further investigation of l3 vertebral compression fracture.The result is as follows, interspinous distraction was maintained, and implant was positioned properly.The patient had lower back and leg pain.

Manufacturer Narrative

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.

Event Description

Additional information was reported from the patient¿s 3 years postoperative crf: forteo® was started and used for compression fracture at l3 observed on (b)(6) 2015.No causal relationship was found with implant.It was the patient matter.The treated part of past laminectomy was unknown.The status was non-serious.No additional operation and treatment was performed.Date of outcome was unknown, but the doctor assessed the patient to be improved.The doctor commented that compression fracture at l3 of the patient was improved.

Event Description

It was reported that lower back and leg pain (observed on unknown date of follow-up) was caused by l3 compression fracture.

Manufacturer Narrative

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following observations were made post-operatively.Two years after the operation: the patient complained of having pain all the time.Three years after the operation: compression fracture at l3.Per surgeon, the cause was thought to be bone fragility.Five years after the operation: compression fracture at l3 was improved as on (b)(6) 2016.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following observations were made 5 years after the operation: patient feels pain at least once in a week in her bottom or legs.Patient has moderately severe pain in her back or bottom.Also, patient feels weakness, pain in her legs or feet.Patient is taking non-narcotic analgesic.The device was considered effective for the patient.

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6179995
• MDR Text Key: 62523679
• Report Number: 1030489-2016-03430
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2012
• Device Catalogue Number: 1-3210
• Device Lot Number: 2237901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 03/27/2017; 09/14/2017; 10/05/2017
• Supplement Dates FDA Received: 02/12/2017; 03/10/2017; 04/06/2017; 09/27/2017; 10/12/2017; 10/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2010
• 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): Other
• Patient Weight: 53