MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	54750016535
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
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 cannot determine the definitive cause of event.
Event or Problem Description
Pre-op diagnosis (revision surgery): right s1 screw deviated procedure: transforaminal lumbar interbody fusion levels involved: l4/5 it was reported that on on an unknown date, post-op, the screw at the right of s1 deviated.Hence, a revision surgery was performed in which the screw(diameter- 6.5 mm) was replaced with screw of diameter 7.5 mm.
Additional Manufacturer Narrative
X-ray review: post-op x-ray images provided for l4-s1 fusion.A pedicle screw appears to transgress the right s1 lateral recess.This is not a migration event, but rather the screw was placed in that trajectory initially.Root cause: surgical technique.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6123606
• Report Number: 1030489-2016-03223
• Device Sequence Number: 464343
• Product Code: NKB
• UDI-Device Identifier: 00643169501089
• UDI-Public: 00643169501089
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2024
• Device Catalogue Number: 54750016535
• Device Lot Number: H5291170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2016
• Supplement Date Received by Manufacturer: Not provided; 11/22/2016
• Initial Report FDA Received Date: 11/23/2016
• Supplement Report FDA Received Date: 11/24/2016; 09/27/2017
• 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: 55 YR