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

Model Number MSB_UNK_SCREW

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Dysphagia/ Odynophagia (1815); Headache (1880); Pain (1994); Seroma (2069); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Paresthesia (4421); Swelling/ Edema (4577)

Event Date 03/19/2021

Event Type  Injury  

Event Description

The information was received from health care provider via a medtronic representative regarding a patient implanted with fibercel tissue for spinal therapy.It was reported that the patient was implanted with recalled fibercel tissue lot.No further symptoms/ complications reported for the event.\additional information received states that the patient was infected with tuberculosis after undergoing spinal surgery.The patient received the contaminated fibercel and as a result, suffered severe permanent injury and pain.Postoperatively, the patient gradually worsened, developing swelling in her neck, numbness and tingling in her right hand, new pressure on her throat, and difficulty swallowing.Two weeks following her surgery, she developed headaches and shoulder and neck pain.Roughly five weeks post-op, the patient called the facility, reporting severe neck pain in her left side with radiation into her collarbone.She had an x-ray of her neck, an mri, and was given a steroid for pain.The results of her tb lab test came back positive on (b)(6) 2021.An mri revealed a large cystic fluid collection in her vertebral soft tissues.X-rays also showed migration of the c4 screw which free floated against the patient¿s esophagus nearly puncturing it.She then underwent a revision and abscess evacuation on (b)(6) 2021, and required another incision and drainage surgery five days later.Due to the extensive swelling around her esophagus, the patient required placement of an endotracheal tube and gastrostomy tube on (b)(6) 2021.The multiweek placement of the endotracheal tube has caused severe damage to the patient¿s throat and vocal cords resulting in pain and distortion of her voice.Potential return of her tb infection in a different area of her spine was suspected after she developed back pain that radiated to her legs causing her difficulty standing and walking.Dr.(b)(6) referred the patient to another facility.On (b)(6) 2022, the patient underwent yet another spinal surgery at another facility.

Manufacturer Narrative

D1,d4: product identifiers are unknown.G4: product identifiers are not known, hence 510k# is unknown.H6: 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.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.

• 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: 18472841
• MDR Text Key: 332376597
• Report Number: 1030489-2024-00028
• Device Sequence Number: 1
• Product Code: NKB
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_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: 01/04/2024
• 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 Sex: Female