MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7560020
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial surgery happened in year 2011 but exact date of implant is unknown.(b)(4) neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.Product image review: submitted images appear to display corroded set screw.
Event or Problem Description
It was reported that patient underwent surgery due to scoliosis on an unknown date.Post-op, there was suspected infection and/or allergic reaction to the metal in the patient.Hence, a revision surgery was performed on (b)(6) 2017 to remove the hardware.The hardware was implanted 6 years ago.When removing the set screws, rods, and screws there was a black, ashy substance around the metal.The superior set screws of the construct were loose and one appeared to be corroded.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional info: product analysis: optical and microscopic examination of the set screws identified severe pitting.Microscopic examination identified crystallographic pitting on the rod interface surface and in the face of the set screw consistent in location and surface morphology with crevice corrosion.The nature, location and surface morphology of the returned implants are consistent with anticipated in-vivo wear due to crevice corrosion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6430873
• Report Number: 1030489-2017-00588
• Device Sequence Number: 18946152
• Product Code: KWP
• UDI-Device Identifier: 00885074464664
• UDI-Public: 00885074464664
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2018

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 Catalogue Number: 7560020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: 02/27/2017; 01/17/2018
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 10/02/2017; 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RODS, SCREWS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 37