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

Catalog Number 7540020

Device Problem Material Deformation (2976)

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

Event Date 04/28/2019

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent spinal fixation surgery due to lumbar disc herniation.Intra-op, threads of set screw were damaged.No patient symptoms or complication were reported as result of this event.

Manufacturer Narrative

Product analysis results: visual optical functional visual and optical 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 a sample mas head found the set screw was still able to be fully engaged.The above observations are consistent with misalignment of the mas head and set screw threads during construct assembly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 8643530
• MDR Text Key: 146235375
• Report Number: 1030489-2019-00582
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00885074457093
• UDI-Public: 00885074457093
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052187
• 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,Followup
• Report Date: 06/26/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 7540020
• Device Lot Number: H5367033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/27/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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