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

Model Number	UQI00010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	08/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
According to (b)(4) the patient was re-admitted to hospital on (b)(6) 2016 after developing a csf leak following decompressive laminectomy for lumbar stenosis on (b)(6) 2016.The patient was reported to have had drainage from her incision.On (b)(6) 2016 the patient underwent the surgical procedure of an l3-4 and l4-l5 decompression with posterior stabilization using coflex device at l3-4 and l4-5.No complications were reported as well as reports postoperatively the patient did well and was discharged home (b)(6) 2016.On (b)(6) 2016 the patient presented to the hospital's emergency department with complaints of "headache/muscle spasms" for previous 24 hours.A ct of head was performed and reported to ed as negative for acute pathology.The patient's headache resolved in ed and she was discharged home with follow up to neurosurgeon.The patient was admitted to the hospital on (b)(6) 2016 by the neurosurgeon for "csf leak".Due to reported csf leak the patient was returned to surgery on (b)(6) 2016 for removal of the hardware (coflex) device and repair of the durotomy.The neurosurgeon operative report revealed 'deep retractors were placed within the wound and the coflex hardware was removed.At the l3-l4 level, there was a small tear in the midline which could be visualized under the microscope, but was otherwise fairly small.No other complications were reported.Cultures obtained at the time also grew staphylococcus aureus with iv antibiotics given.The patient had control of pain and no further evidence of csf leak was identified.Patient was discharged home on (b)(6) 2016 with home physical therapy and pain medication.No known device problem reported.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER
• Manufacturer (Section D): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• MDR Report Key: 6092693
• Report Number: 3005725110-2016-00005
• Device Sequence Number: 10951957
• Product Code: NQO
• UDI-Device Identifier: 04260148898518
• UDI-Public: (01)04260148898518(17)191031(10)2014003305,(01)04260148898518(17)191231(10)2014003463
• 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: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/10/2016

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: No Information
• Device Expiration Date: 10/31/2019
• Device Model Number: UQI00010
• Device Catalogue Number: UQI00010
• Device Lot Number: 2014003305, 2014003463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 11/10/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Weight: 93