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

Catalog Number	5540430
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: macroscopic and optical examination revealed thread crest and flank damage; this damage appears to have initiated at the start of the thread, and is consistent around the damaged portion of the thread.Functional evaluation with a sample mas found the implant unable to be fully engaged into the mas head.This type of damage is 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
It was reported that the patient underwent surgery at l4-iliac.Intra-op, the set screw could not be fixed in the screw.After two unsuccessful attempts to fix the set screws, the physician decided to switch the screws too.From physician's experience, he decided not to implant the set screws at all; and the procedure was completed.No patient complications were reported.

• Brand Name: CD HORIZON 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: 8830398
• Report Number: 1030489-2019-00819
• Device Sequence Number: 2119173
• Product Code: NKB
• UDI-Device Identifier: 00643169007994
• UDI-Public: 00643169007994
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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 Catalogue Number: 5540430
• Device Lot Number: H5520578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 56