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

Model Number MSB_UNK_SCREW

Device Problem Break (1069)

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

Event Date 10/15/2022

Event Type  malfunction  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.Product identifiers are unknown.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.Zhuang zhang, bo-wen hu, liang wang, hui-liang yang, tao li, li-min liu, xi yang, yue-ming song.¿comparison of long-term outcomes between the n-ha/pa66 cage and the peek cage used in transforaminal lumbar interbody fusion for lumbar degenerative disease: a matched-pair case control study.¿ orthopaedic surgery.15.2023:152¿161.Doi: 10.1111/os.13593.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Zhuang zhang, bo-wen hu, liang wang, hui-liang yang, tao li, li-min liu, xi yang, yue-ming song.¿comparison of long-term outcomes between the n-ha/pa66 cage and the peek cage used in transforaminal lumbar interbody fusion for lumbar degenerative disease: a matched-pair case control study.¿ orthopaedic surgery.15.2023:152¿161.Doi: 10.1111/os.13593.Summary: the nanohydroxyapatite/polyamide-66 (n-ha/pa66) cage is a novel bioactive nonmetal cage that is now used in some medical centers, while the polyetheretherketone (peek) cage is a typical device that has been widely used for decades with excellent clinical outcomes.Cage subsidence is a common complication after tlif and is associated with fusion failures and poor clinical outcomes.It is influenced by the lower fused segment, amount of morselized bone, number of fused segments, endplate manipulation, cage size, cage position, and the material characteristics of the cage.Reported events: 30 patients had cage subsidence who were implanted with peek cage.One patient had cerebrospinal fluid leakage and resolved completely by conservative treatment.One patient had wound infection and resolved completely by conservative treatment.One patient had nerve root injury and resolved completely by conservative treatment.See attached literature article.

• Brand Name: UNKNOWN
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 16680634
• MDR Text Key: 313239884
• Report Number: 1030489-2023-00243
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• 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: 56 YR
• Patient Sex: Female