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

Catalog Number 1-3212

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Swelling (2091); No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2012

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

Event Description

It was reported that the patient was pre-operatively diagnosed with lumbar spinal canal stenosis and was enrolled in post market study.Post-op, the loosening of implant was reported at l4-l5.A revision surgery was performed for the removal and re-insertion of another implant.The patient was withdrawn from study on (b)(6) because surgical treatment accompanied by removal of this product was necessary, and it became difficult to continue to investigate the safety and efficacy of this product.

Manufacturer Narrative

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

Event Description

On (b)(6) 2012, an implant (12mm) was inserted.Intra-operative x-rays confirmed proper device positioning.On (b)(6) 2012, the patient came to the hospital for lower-limb swelling.On (b)(6) 2012, it was confirmed that the implant was loosened by a lumbar vertebra x-ray photograph.On (b)(6) 2014, device was removed in another hospital.And the implant was replaced with a 14mm one.Per clinical investigation, surgical treatment including removal of the subjected medical device made it difficult to evaluate the safety and efficacy of the device.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7026578
• MDR Text Key: 91895609
• Report Number: 1030489-2017-02323
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00643169132825
• UDI-Public: 00643169132825
• 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
• Report Date: 04/13/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2012
• Device Catalogue Number: 1-3212
• Device Lot Number: 2228531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 04/09/2018
• Supplement Dates FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2010
• 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): Required Intervention
• Patient Age: 86 YR