MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCREW

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

The mean age was 68.1 years (range 30-83 years).18 male and 42 female.Country: (b)(6).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

Ryo tamaki, keiji wada, ken okazaki "surgical technique and accuracy of s2 alar-iliac screw insertion using intraoperative o-arm navigation: an analysis of 120 screws" world neurosurg.(2020) 144:e326-e330 summary : this study was for the evaluation the surgical technique and accuracy of sai screw placement using the o-arm.This study involved 60 patients who underwent sai screw placement using the o-arm system between september 2013 and september 2019.These surgeries were performed by 5 different surgeons.For o-arm-based sai screw insertion, a reference frame was attached to the spinous process of the lower lumbar spine (usually l4) so as not to interfere with sai screw insertion and to facilitate simultaneous l5-s posterior interbody fusion with navigation.The navigated probe, iliac tap, and screwdriver were used for sai screw insertion.Screw placement accuracy and screw length were assessed using postoperative computed tomography.The screw placement was defined as accurate if the screw did not breach any cortex of the sacral or iliac bone.Perioperative complications were also evaluated.Reported event: mean age at surgery was 68.1 (range, 30e83) years.A total of 120 sai screws were placed.The diameter of all screws was 7.5 or 8.5 mm.Mean screw length was 82.8 mm: 42 were 90 mm, 71were 80 mm, 6 were 70 mm, and 1 was 60 mm.Two of the 120 (1.7%) screws were misplaced, breaching the lateral edge of the anterior sacral cortex.Rate of accurate screw placement was 98.3% (118/120 screws).There were no significant neurovascular or visceral complications perioperatively.No complications related to screw placement were observed.

• Brand Name: UNKNOWN
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 12055962
• MDR Text Key: 265803644
• Report Number: 1030489-2021-00841
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• 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 Age: 68 YR