MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PRESTIGE LP; PROSTHESIS, INTERVERTEBRAL DISC

Model Number MSB_UNK_PREST_LP

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); Neuropathy (1983); Pain (1994)

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

B.3.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not p rovided in the published literature.D.4, g.4.Product identifiers are unknown.H.6.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.Evan d.Nigh, ryan a.Finkel, arash j.Sayari, todd h.Lanman, eli m.Baron, and jason m cuellar."an atypical presentation of early periprosthetic infection after cervical disc arthroplasty".Jbjs case connector.2023;13:e22.00679.Doi: 10.2106/jbjs.Cc.22.00679.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

Evan d.Nigh, ryan a.Finkel, arash j.Sayari, todd h.Lanman, eli m.Baron, and jason m cuellar."an atypical presentation of early periprosthetic infection after cervical disc arthroplasty".Jbjs case connector.2023;13:e22.00679.Doi: 10.2106/jbjs.Cc.22.00679.Summary: most complications from cervical disc arthroplasty (cda) can be attributed to the anterior approach or patient selection/surgical technique errors1-3.Deep infection after cda is rare and usually stems from missed esophageal injury.This report of implant-related infection after cda is the sixth in the literature, and there is limited understanding of its presentation, diagnosis, and treatment.A case of cda failure due to infection with an atypical pathogen in a patient with klippel-feil syndrome (kfs), along with a review of the literature.Reported event: a 22-year-old woman with klippel-feil syndrome who underwent cervical disc arthroplasty (cda) presented 3 months postoperatively with worsening neck pain and radiculopathy.Work-up was negative for infection, but singlephoton emission computed tomography revealed increased metabolic activity in the vertebral body below the implant.Duringrevision, the implant was grossly loose and multiple cultures grew cutibacterium acnes.She was treated with an antibiotic course and conversion to anterior fusion without recurrence.See attached literature article.

• Brand Name: PRESTIGE LP
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18674714
• MDR Text Key: 334949468
• Report Number: 1030489-2024-00103
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_PREST_LP
• Device Catalogue Number: MSB_UNK_PREST_LP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• 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
• Patient Age: 22 YR
• Patient Sex: Female