MAUDE Adverse Event Report: MSD BARTLETT MFG PRESTIGE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6971155
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2020
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 manufacturer representative regarding an event that occurred during an anterior artificial disc replacement surgery on a patient diagnosed with cervical disc disease.It was reported that for the prosthesis with a height of 5mm, the prosthesis holder could not hold the prosthesis, and only 6mm prosthesis could be replaced intra-operatively for implantation.Product will be returned and will be replaced with a medtronic product.No patient injury / complication was reported.

• Brand Name: PRESTIGE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• MDR Report Key: 10447185
• Report Number: 1030489-2020-01142
• Device Sequence Number: 19681975
• Product Code: LXH
• UDI-Device Identifier: 00885074309644
• UDI-Public: 00885074309644
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 08/25/2020

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: 6971155
• Device Catalogue Number: 6971155
• Device Lot Number: MA07J062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR