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

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2019

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8830446
• MDR Text Key: 152537240
• Report Number: 1030489-2019-00822
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169007994
• UDI-Public: 00643169007994
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 56