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

Catalog Number	779115555
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(revision surgery and increased kyphosis) neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient underwent an unspecified spinal procedure on an unknown date at levels "d4-s1".Post-op, patient had back pain and high kyphosis due to the fact that the set screw from connector was unscrewed.There was no more connection between superior and inferior construct which was linked by the connector.A revision surgery(posterior fixation) was thus performed on (b)(6) 2017 to explant the connector and replace it with domino connector.
Additional Manufacturer Narrative
Additional information: image review: x-ray image review: single post-op x-ray/pre-revision shows separation of the construct- level unknown.The reported complication is loose set screw.Construct failure would be expected if a connector was used to link the long thoracic and lumbar segments at a single level.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: 6783811
• Report Number: 1030489-2017-01893
• Device Sequence Number: 18983473
• Product Code: KWP
• UDI-Device Identifier: 00613994739353
• UDI-Public: 00613994739353
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K101074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

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: 779115555
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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