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

Catalog Number 1-3208

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

Patient Problem Pain (1994)

Event Date 10/10/2014

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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

It was reported that: the female patient underwent a surgery to place two implants (one each at l3/l4 and l4/l5) without any intraoperative adverse events.Diabetes mellitus was reported as her concurrent disease.The patient was hospitalized for the surgery on (b)(6) 2012 and was discharged on (b)(6) 2012.No postoperative adverse event or implant failure was reported during the first year after the surgery.According to the patient's 2-year postoperative crf, pain recurred.On the same day, ct was performed due to the patient's complaint of intense pain in the right lower extremity, showing no abnormality such as implant migration, etc.The pain was treated with analgesic medications.The event severity was non-serious.The event outcome was unknown.The physician considered that the causal relationship between the event of postoperative recurrence of pain and implant could not be ruled out.The product came in contact with the patient.Patient complications were reported.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5153272
• MDR Text Key: 28398648
• Report Number: 1030489-2015-02687
• 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
• Reporter Occupation: Health Professional
• Report Date: 10/01/2015

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: 03/07/2013
• Device Catalogue Number: 1-3208
• Device Lot Number: 2253691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2011
• 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): Other
• Patient Age: 00075 YR
• Patient Weight: 56