MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PAK NEEDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8670010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Type of Reportable Event	Serious Injury
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 healthcare professional via field representative regarding patient with symptoms of lumbar spondylolis thesis involved in olif+pps procedure used in spinal therapy.Levels implanted: l4/5.It was reported during use, superior adjacent segment disease in patient was reported.There was no malfunction of the product reported.The bone was fragile originally because of steroids, rheumatism or dialysis.Removal of rod and set screw was planned on (b)(6) 2020.There was no plan to remove cage in revision surgery.Quantity-2 screws were removed on l5, but lot# is unknown.There was no malfunction of implanted products.Olif was performed on l4/5, posterior sentant was performed.Due to adjacent segment disease on l3/4, it was planned to perform olif on l3/4 and insert pps in l3 and perform connection on l3-5 on (b)(6).Additional information regarding the re-operation: bone fusion was achieved completely on l4/5, screw on l5 was removed.Olif was performed between l3/4, posterior fusion on l3/4 with pps was performed and the operation was completed.Patient status is unknown, but movement of leg right after the operation was well.

• Brand Name: PAK NEEDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10733858
• Report Number: 1030489-2020-01486
• Device Sequence Number: 17014966
• Product Code: LXH
• UDI-Device Identifier: 00721902756351
• UDI-Public: 00721902756351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 8670010
• Device Catalogue Number: 8670010
• Device Lot Number: 0322909W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention