MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG OC BONE SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number G360T0414

Device Problems Mechanical Jam (2983); No Apparent Adverse Event (3189)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not 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 professional via manufacturer representative regarding a patient who was implanted with a spinal product type for o-c2 posterior fusion procedure.It was reported that, during intra-operative procedure, the screw was unable to be removed from the driver.The oc bone screw stuck to the tapered driver and was unable to be removed.The event occurred at the time of inserting the first screw, it was managed to be removed, but the event also occurred on the second one and the screw was unable to be removed.Instead of forcibly pulling it out, it was attempted to be removed out of the operative field, but a considerable force was required.As the screw was able to be removed somehow, it was changed to a flexible type driver and it was able to be inserted somehow.The screw guide was not used no patient complications or symptoms were reported at the time the event took place.

Event Description

2020-aug-20 e4: additional information was received , there was no patient involved, the screws did not came in contact with the patient and there was no malfunction with the screw itself.Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.B5:additional information was received resulted in the change of the event description d4: model number added as per new information.H6:additional information was received resulted in the change in device code and patient code (non-reportable).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: OC BONE SCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 10395305
• MDR Text Key: 202599423
• Report Number: 1030489-2020-01079
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G360T0414
• Device Catalogue Number: G360T0414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1