MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7543645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
T was reported that patient underwent surgery due to lumbar disc protrusion in which spinal instrumentation was implanted.Post-op, around the middle of (b)(6) 2016, one screw was found broken.Patient underwent replacement surgery on (b)(6) 2016 in which screws were replaced with other manufacturer's products.
Additional Manufacturer Narrative
X-ray review: pre-op and post-op x-rays are shown for l5-s1 plif.Per report a 5.5 mm system was used with spacer.One of the sacral screws appears to be fractured.There is a paucity of bone growth through the interbody spacer at l5/s1 additionally at 8 months post-op likely contributing to the construct failure.
Additional Manufacturer Narrative
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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6248749
• Report Number: 1030489-2017-00092
• Device Sequence Number: 1025186
• Product Code: KWP
• UDI-Device Identifier: 00721902857539
• UDI-Public: 00721902857539
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2017

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: 7543645
• Device Lot Number: H5162458
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided; 01/24/2017
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 01/27/2017; 09/28/2017
• 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
• Patient Age: 60 YR