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	6530530
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual and microscopic examination revealed thread crest/flank damage; this damage appears to have initiated near the start of the thread and is evident around the damaged portion of the thread.Functional evaluation with sample mas head confirmed the set screw was still able to be fully engaged.The above observations are consistent with misalignment of the mas and set screw threads during construct assembly.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre operative diagnosis: spinal canal stenosis procedure used: l3/4/5 oblique lumbar interbody fusion (olif) , l5/s posterior lumbar interbody fusion(plif) l3/s; pedicle screw fixation(pps) levels implanted: l3/s it was reported that intra-op, after placing the set screw, compression was performed with fulcrum, and attempted to break off the set screw which was placed on left l5, but it could not be broken off.When attempted to remove the driver of the set screw and attach it again, the set screw could not be gripped.The set screw was removed by the driver, and new set screw was placed but again it could not be broken off, the screw was replaced and broken off, and the operation was completed.There was a delay of less than 60 min in overall procedure time as a result of this event.The product came in contact with the patient.No patient symptoms or complication were reported as result of this event.

• 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: 8481592
• Report Number: 1030489-2019-00386
• Device Sequence Number: 1922336
• Product Code: NKB
• UDI-Device Identifier: 00643169750258
• UDI-Public: 00643169750258
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2026
• Device Catalogue Number: 6530530
• Device Lot Number: H5413256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1