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

Catalog Number 1-3206

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

Patient Problems Bone Fracture(s) (1870); Claudication (2550)

Event Date 05/23/2012

Event Type  Injury  

Event Description

It was reported that a patient underwent a surgery to place two interspinous process spacer devices (one each at l3/l4 and l4/l5) without any intraoperative adverse events.Fourteen days post-op, postoperative spinous process fracture was noted.Symptoms in the lower limb relapsed.No additional intervention and treatment were required for the event.The event severity was non-serious.The event outcome was reported to be unknown on (b)(6) 2012 because the patient was transferred to another hospital.The physician considered that the causal relationship between the event of spinous process fracture and spacer could not be ruled out.The patient was withdrawn from pms on (b)(6) 2012 due to the transfer to another hospital.The physician judged the interspinous process spacer as ineffective in this patient.No other complications were reported.

Manufacturer Narrative

(b)(6).(b)(4).Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

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

It was reported that on may 23, 2017, patient's 12 month post-operative crf report was received which revealed that the operation date was revised from (b)(6) 2012 to (b)(6), 2012.The date of hospital setting was revised from (b)(6) 2012 to (b)(6) 2012, and the date of discharge was revised from (b)(6) 2012 to (b)(6) 2012.The date of the cancellation of pms was revised from june 25, 2012 to july 23, 2012.The outcome date that spinous process fracture developed in the patient was revised from june 25, 2015 to july 23, 2015.The outcome evaluation was revised from "unknown" to "improved".The doctor said, "the patient's condition became exacerbated temporarily on (b)(6).But pain relieved at follow up examination on (b)(6).".

Event Description

Additional information was reported from the patient¿s 1,2,3 years postoperative crf on (b)(6) 2017.We were reported that a case data other than this case was mistakenly input in the questionnaire of the case number by the doctor in charge and then the corrected case data was input in the questionnaire by the doctor in charge.The corrected data of the patient were (b)(6).The patient did not visit the hospital on (b)(6) 2014, so that the doctor could not interview the patient.On (b)(6) 2015 x-ray photography revealed that maintenance of interspinous enlargement and placement of the implant was appropriate at regular follow-up.However, since then, the patient did not visit the hospital for the interview due to moving.The follow-up was decided to cancel on (b)(6) 2015.The doctor in charge evaluated that the treatment was effective to the patient.

Manufacturer Narrative

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

Event Description

Additional info received from the patient¿s 1,2,3 years postoperative crf on (b)(6) 2017: for spinous process reportedly having developed on (b)(6) 2012 (postoperatively), the doctor commented ¿the date was incorrectly entered; there was no adverse event/malfunction.¿ patient underwent imaging examinations: [preoperatively] (b)(6) 2012: used imaging: x-ray and mri [intraoperatively] interspinous distraction: maintained.Implant positioning: appropriate [post-op 1-month] (b)(6) 2012: interspinous distraction: maintained.Implant positioning: inappropriate.Used imaging: x-ray.[post-op 12-month] (b)(6) 2013: interspinous distraction: maintained.Implant positioning: inappropriate.Used imaging: x-ray.[unscheduled examination] (b)(6) 2012: the reason why examination was carried out: for a follow-up.Interspinous distraction: maintained.Implant positioning: appropriate.Used imaging: mri.

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4795944
• MDR Text Key: 20723423
• Report Number: 1030489-2015-01042
• 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,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2017

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 Catalogue Number: 1-3206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/26/2015
• Supplement Dates Manufacturer Received: Not provided; 06/26/2017; 09/11/2017
• Supplement Dates FDA Received: 06/05/2017; 07/21/2017; 10/09/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 00072 YR
• Patient Weight: 53