MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 54740007540

Device Problem Device Dislodged or Dislocated (2923)

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

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.This part is not approved for use in the us, however a like device with part# 54840007540, 510k# k091974 and upn 00613994589309 is approved for market in the us.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient with an unknown indica tion for plf and vertebroplasty.It was reported that in the initial operation, perhaps for l4 burst, vertebroplasty was performed at l4 with hoyapentax company's ha block, and ps was inserted and fixed at l3 and l5.According to a medical practitioner's introduction, the patient visited the hospital on 8/12 on the reported day, and the patient was found to be paralyzed at the time of the examination by the physician.Purulent discitis was suspected between l2 / 3.Reoperation was scheduled for the day after the reported day 8/13.The cause why purulent discitis occurred at such a level between l2 / 3, was unknown.However, l3ps removal for decompression, l5ps removal due to looseness, and replacement from the system s4 to v5 were scheduled.The lot of l5ps was unknown because the lot used were disjointed.Just in case, all the products used for the initial surgery were attached in excel.It's not that there was a malfunction, but they removed all the products to replace the system, and all the removed products were returned to the patient.Additional information received from manufacturer representative that re-operation was performed on (b)(6) 2021.Patient medical history: asthma, alcohol poisoning 10 years ago.In the re-operation, all the systems currently in use were removed, and there had looseness on both sides of l5.At l4, vertebroplasty was performed with hoyapentax ha block, and only the plug was removed.L2 / 3 disc was curetted and autologous iliac bone grafted.Pps was inserted additionally into t12 / l1, ps was inserted in l4 where the ha block was implanted and l5.Ha stick was used in combination at l5.Lamina hook was placed from the lower on both sides of l5 (pps was used without opening at the upper, ps was inserted by opening at the lower).It was connected at t12-l5, and the prolock was placed between l4 / 5 and the procedure was completed.The cause is unknown after all.Although intraoperative culture had been performed, the result was unknown because it did not appear during the operation.Additional information received from manufacturer representative that according to the physician, there might have been a screw out to the intervertebral disc, but it could not be confirmed from images such as ct.It's just a matter of possibility.The exact reason for paralysis and discitis was unknown.2 out of 4 screws were loose.The other two had no malfunctions, they were removed because they interfered with decompression.Medical safety assesses the reported event of ¿paralysis and discitis¿ and its reported severity as not related to the device or therapy but instead is an inherent surgical risk associated with spine fusion surgery.The information obtained indicates that the device performed as intended in this case.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: david gustafson ; 1800 pyramid place; memphis, TN 38132 ; 7635149628
• MDR Report Key: 12428607
• MDR Text Key: 270343402
• Report Number: 1030489-2021-01119
• 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: 09/06/2021

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 Expiration Date: 06/04/2020
• Device Model Number: 54740007540
• Device Catalogue Number: 54740007540
• Device Lot Number: H12E0153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/06/2021
• 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: 58 YR
• Patient Weight: 65