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

Model Number MSB_UNK_SCREW

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 10/22/2021

Event Type  Injury  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with spinal therapy.It was reported that the driver broke during screw insertion.This was a revision surgery for l5/s radicular symptom.Screw was loosened and was removed.There was a delay of less than 60 min in overall procedure time.There was no fragment left in the patient.There were no symptoms reported.There were no further complications reported regarding the event.

Manufacturer Narrative

The event was incorrectly reported as reportable malfunction but is si reportable due to reoperation of loosened screw.Hence, corrections were made in b1, b2, b5, d1, d4, d6a, d6b, annex f code, h1, and h6.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

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient implanted with a screw using a driver in a posterior fusion for an l5/s radicular symptom.It was reported that the driver broke during screw insertion.There were no fragments of the driver and screw remaining in the patient's body.Neurological symptom developed after the initial operation leading to reoperation.At the time of reoperation, the screw previously implanted in l5 was loose and hence removed.Another screw was inserted in its place without additional tapping when the driver broke.Considering the possibility that the screw was too long, they changed the screw and replaced the driver and inserted the screw.The event was associated with a patient.There were no patient symptoms or complications as a result of this event.This was a revision surgery for l5/s radicular symptom.Initial surgery took place on 6-dec-19.There was a delay of less than 60 minutes in overall procedure time.There was no in-patient hospitalization or prolongation of existing hospitalization necessary and no treatment or additional surgery performed as a result of this event.The date of initial screw implant was (b)(6) 2019 and date of initia l screw explant was (b)(6)2021.The date of replacement screw implant/ explant was (b)(6) 2021.The patient's medical history included dish.No further complications were reported/ anticipated.

• 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: 12826004
• MDR Text Key: 285475939
• Report Number: 1030489-2021-01406
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• 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: 11/02/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 101 KG