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

Catalog Number	1-3212
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Swelling (2091); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2012
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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reported at l4-l5.A revision surgery was performed for the removal and re-insertion of another implant.The patient was withdrawn from study on (b)(6) because surgical treatment accompanied by removal of this product was necessary, and it became difficult to continue to investigate the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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7026578
• Report Number: 1030489-2017-02323
• Device Sequence Number: 944783
• Product Code: NQO
• UDI-Device Identifier: 00643169132825
• UDI-Public: 00643169132825
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2012
• Device Catalogue Number: 1-3212
• Device Lot Number: 2228531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR