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

Catalog Number 54740005540

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 54840005540, 510k # k091974 was cleared in the united states.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 on an unknown date, post-op, the implanted screw was broken.Removal operation was performed after bone fusion had achieved.During revision surgery, pre-operatively, the doctor saw the image and the screw on right side of s1 was suspected to be broken.When the screw was attempted to be removed actually, only the screw head and the base part of the screw shaft could be removed, and the shaft part remained inside the patient's sacrum.The wound was closed in that situation.No patient symptoms or complications were reported as a result of this event.

Manufacturer Narrative

Product analysis result: visual microscopic visual examination of the mas bone screw confirmed a complete fracture at the neck of the screw, just below the head.The head is angulated and jammed to the shaft of the bone screw.Microscopic examination of the fracture surface noted smearing and damage.Microscopic examination of the fracture surface identified progressive striations in some undamaged areas, which are indicative of cyclic fatigue that could have been accelerated by steep angulation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7758790
• MDR Text Key: 116296838
• Report Number: 1030489-2018-01103
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2022
• Device Catalogue Number: 54740005540
• Device Lot Number: H5091479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2014
• 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): Required Intervention