MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 54310006535

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): this part is not approved for use in the united states; however, a like device catalog #54840004540, 510k #k091974 and udi#(b)(4) 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

Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of spinal canal stenosis at l4/5, undergoing a spinal therapy.It was reported that fas screw was inserted into l5.The plug could not be threaded at the time of final tightening and it idled.There was a clear sense of abnormality, so when the surgical field was checked, one side of the screw head of the item was broken about half.Therefore, it was removed, replaced with mas screw to cope with the problem.It is possible that the set screw was cross-threaded, but the screw head broke.At final tightening, counter was used.There was a delay of less than 60 mins.There were no patient symptoms/complications.Doctor commented that maybe it was a matter of skill.Initial reporter information cannot be provided due to the restriction by the privacy regulation.The reported product was discarded in hospital.Additional information received.There was no deformation on the screw.The doctor recognized it to be a user error.Procedure/therapy: plf at one intervertebral disc.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11299313
• MDR Text Key: 230973210
• Report Number: 2647346-2021-00007
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54310006535
• Device Catalogue Number: 54310006535
• Device Lot Number: H5524721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2021
• Date Device Manufactured: 04/26/2019
• 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