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

Model Number 8670010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

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 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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10733802
• MDR Text Key: 213064418
• Report Number: 1030489-2020-01485
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00721902756351
• UDI-Public: 00721902756351
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2019
• Device Model Number: 8670010
• Device Catalogue Number: 8670010
• Device Lot Number: 0299159W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Date Device Manufactured: 02/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention