MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	G3602537
Medical Device Problem Codes	Material Deformation (2976); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via field representative regarding patient with symptoms of dislocation fracture at c7 involved in c2-t3 fixation was performed and c7 was skipped for c7 dislocation fracture.Levels implanted- c2-t3.It was reported that at intra-op, the outer set screw stripped when the crosslink was finally tightened.Implant did not break.Product was used correctly according to the directions given in the ifu/labeling.Product was not implanted in the patient.There was no delay in overall procedure time.Patient was not hospitalized prolong.There were no patient symptoms/complications reported as a result of the event.No health damage in the patient was reported.On 2021-mar-04, received additional information that set screw hole screw threads of both arms were scratched, upper arm set screw tip slightly scratched, and hex hole was stripped.The center of screw hex hole was also slightly stripped.Both the drivers were stripped at tip.One of the driver could not mate with the sample infinity set screw m6.Another driver could mate with the returned if rod crosslink l.If torque limiting handle had no obvious defect in appearance.The handle lever worked smoothly, and it could be attached and detached to both of the returned if torque limiting drivers.The product came in contact with the patient because the event occurred at the time of final tightening of crosslink.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11442401
• Report Number: 1030489-2021-00320
• Device Sequence Number: 16941669
• Product Code: KWP
• UDI-Device Identifier: 00643169549487
• UDI-Public: 00643169549487
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G3602537
• Device Catalogue Number: G3602537
• Device Lot Number: RM19B016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1