MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CAPSTONE PEEK VERT BODY SPACER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2980008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Information was received from a healthcare provider (hcp) via a medtronic representative regarding a patient implanted with a spacer using an inserter in a l4-5 plif for an l4-5 stenosis.It was reported that the surgeon implanted the spacer in the l4-5 space on the left side.A piece of the inserter broke.The hcp recovered the broken piece and a backup inserter was used for the other implant. there were no patient symptoms or complications as a result of this event.There was no treatment or additional surgery performed as a result of this event.No further complications were reported/ anticipated.

• Brand Name: CAPSTONE PEEK VERT BODY SPACER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13857281
• Report Number: 1030489-2022-00273
• Device Sequence Number: 1322373
• Product Code: LXH
• UDI-Device Identifier: 00885074318035
• UDI-Public: 00885074318035
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/22/2022

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: 2980008
• Device Catalogue Number: 2980008
• Device Lot Number: MC11K002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/23/2022
• Date Device Manufactured: 10/01/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male