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

Catalog Number 55840014540

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 10/04/2018

Event Type  Injury  

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

Type of procedure or technique used: percutaneous osteosynthesis it was reported that post-op, the patient was re-operated because the screw of the assembly were torn off.It was observed that the 4.5 diameter screw was no longer poly- axial but locked with angulation, hence they had been torn off.

Manufacturer Narrative

Product analysis result: visual optical visual and optical inspection confirmed the screw was locked in an angulated position.It appears the screw has been overtightened pushing the crown and cannulated screw down into the locking c-ring causing the multi-axial function of the screw to lock up.Witness marks on the crown of the screw where the rod is seated and tightened is noted.This is consistent with excessive force/torsional overload.If information is provided in the future, a supplemental report will be issued.

• 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: 8072822
• MDR Text Key: 127201650
• Report Number: 1030489-2018-01487
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169076860
• UDI-Public: 00643169076860
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 55840014540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• 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 Outcome(s): Other; Required Intervention