MAUDE Adverse Event Report: PARADIGM SPINE GMBH COFLEX INTERLAMINAR TECHNOLOGY; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number	UQI00012
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per mdr (b)(4): "the patient originally underwent a surgery for l3 4 l4 5 decompressive laminectomy for lumbar spinal stenosis with posterior stabilization using the coflex interspinous process clamp on (b)(6) 2016.No complications were reported during the original procedure.The patient did return for hospitalization on (b)(6) 2016 for development of drainage from the incision site that did not subside.On (b)(6) 2016 the patient again returned to the hospital for a surgical procedure related to loose orthopedic implant and removal of the posterior spinal instrumentation.The neurosurgeon documented that the patient recently was seen for with complaints of increasing lower back pain associated with movement.The documentation revealed that it was somewhat more on the left side than the right and x-rays were obtained that showed the coflex device had migrated posteriorly and was no longer in the interspinous space.Removal was done in hopes of helping the patient with his residual back pain.The neurosurgeon documented that flexion extension x-rays failed to show any obvious instability.Post-operative mri scan showed successful decompression of the spinal canal.No further information was available and no specific documentation was found that the devices had specific concerns.".

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• MDR Report Key: 6185169
• Report Number: 3005725110-2016-00006
• Device Sequence Number: 1004069
• Product Code: NQO
• UDI-Device Identifier: 04260148898525
• UDI-Public: (01)04260148898525(17)191231(10)2014003575
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/19/2016

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
• Operator of Device: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: UQI00012
• Device Catalogue Number: UQI00012
• Device Lot Number: 2014003575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2016
• Initial Report FDA Received Date: 12/19/2016
• 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: Hospitalization
• Patient Age: 53 YR
• Patient Weight: 57