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

Model Number	UQI00014
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgery performed on (b)(6) 2017 was a decompression with coflex interlaminar stabilization at the l4/5 level.Post-operative x-rays performed did not identify any acute injuries or fracture.Initial post-op assessment on pod#1 patient reported complete resolution of bilateral leg and hip pain, however continued to complain of lower back pain rated 6-7 of 10.Pod#2 patient had an active day of shopping and began to complain of increased pain which she attributed to too much activity.Pain continued to increase.Ct scan identified a fracture of the l4 spinous process.Upon further evaluation, it was determined that the best course of action would be to re-explore the surgical area.Re-exploration of area occurred on (b)(6) 2017.During the operation, the coflex was removed, as was the broken spinous process.Patient recovered and is doing well post-operatively.
Event or Problem Description
The surgery performed on (b)(6) 2017 was a decompression with coflex interlaminar stabilization at the l4/5 level.Post-operative x-rays performed did not identify any acute injuries or fracture.Initial post-op assessment on pod#1 patient reported complete resolution of bilateral leg and hip pain, however continued to complain of lower back pain rated 6-7 of 10.Pod#2 patient had an active day of shopping and began to complain of increased pain which she attributed to too much activity.Pain continued to increase.Ct scan identified a fracture of the l4 spinous process.Upon further evaluation, it was determined that the best course of action would be to re-explore the surgical area.Re-exploration of area occurred on (b)(6) 2017.During the operation, the coflex was removed, as was the broken spinous process.Patient recovered and is doing well post-operatively.
Event or Problem Description
The surgery performed on (b)(6) 2017 was a decompression with coflex interlaminar stabilization at the l4/5 level.Post-operative x-rays performed did not identify any acute injuries or fracture.Initial post-op assessment on pod#1 patient reported complete resolution of bilateral leg and hip pain, however continued to complain of lower back pain rated 6-7 of 10.Pod#2 patient had an active day of shopping and began to complain of increased pain which she attributed to too much activity.Pain continued to increase.Ct scan identified a fracture of the l4 spinous process.Upon further evaluation, it was determined that the best course of action would be to re-explore the surgical area.Re-exploration of area occurred on (b)(6) 2017.During the operation, the coflex was removed, as was the broken spinous process.Patient recovered and is doing well post-operatively.

• 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: 7208962
• Report Number: 3005725110-2018-00001
• Device Sequence Number: 764146
• Product Code: NQO
• UDI-Device Identifier: 04260148898532
• UDI-Public: (01)04260148898532(17)200630(10)2015001677
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P110008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 06/30/2020
• Device Model Number: UQI00014
• Device Catalogue Number: UQI00014
• Device Lot Number: 2015001677
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 12/20/2017; 12/20/2017
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 02/22/2018; 03/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention