MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CENTERPIECE CONNECT PLATE FIXATION SYSTEM; ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Model Number G8530205

Device Problems Difficult to Insert (1316); Mechanical Problem (1384)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510k (2020 reports): this product is not marketed in us but a similar device with catalog # 853-465, udi# (b)(4) and 510k# k050082 is approved for sale in us.Neither the product nor applicable imaging films were returned to manufacturer for evaluation therefore we cannot determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider via a field contact regarding a patient with a pre-operative diagnosis of cervical spine opll, undergoing a spinal therapy.It was reported that, depending on the patient's bone quality, the cortical could not be passed through with a pilot hole of a 1 mm drill.The centerpiece connect and gull-wing plate were placed and pilot hole was created with a 1 mm high speed drill.It was drilled through until the cortex contralateral to lamina and the reported product was used.At that time, the f2.0 mm screw idled without passing through the contralateral side.Due to the blunt shape of the tip of the screw, the cortical could not be passed through with a pilot hole of a 1 mm drill depending on the patient's bone quality.The physician also tried to insert several times, but at that time, stress was applied to the hinge part of lamina and it partially fractured.The tip was changed to a 2mm drill, and the rescue f2.4 was used for dealing with it.As a result, the effectiveness of the screw could be achieved without any problem, but lamina was in a floating state.There was a delay of less than 60 minutes.The products were discarded because the patient had hepatitis b +.Device status reason : never implanted procedure: bone graft on hinge part (combined with gr) levels implanted: c3/4/5/6 when the first screw (lot: w745281) was inserted, it did not pass through the contralateral cortical bone and idled.At that time, the hinge part broke and floated (some were stuck).Therefore, a screw with an increased size was reinserted, and it could pass through the contralateral cortical bone and be placed without any problem.Because such a situation occurred with the first one, the second screw (lot: w743771) that had been prepared was not used, the contralateral side was also changed to place a screw with an increased size.It was reported that the screw caused/contributed to the fracture.Because the screw with f2.0mm did not enter the hole that created with 1mm midas bar in the contralateral cortex, the force to push the lamina inward was applied, so the lamina fractured.There was no other malfunction with the screws other than idling.So far, there was no health issue such as hematoma or restenosis in the patient.Procedure/therapy type: c3/6 laminoplasty (kurokawa method) it was unknown if the second screw had any malfunction as it was not used.This event cannot be considered as a user error.Although it overlaps with the content of the report, as described in the surgical technique, the screw was inserted into the place where the pilot hole was created using 1.0 mm midas, but it did not pass through to the contralateral side.The physician had operated carefully.There was no user error.It was said that when aiming for bicortical according to bone quality, it was necessary to carefully consider the size of the pilot hole.

• Brand Name: CENTERPIECE CONNECT PLATE FIXATION SYSTEM
• Type of Device: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
• 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: 11892128
• MDR Text Key: 252905500
• Report Number: 1030489-2021-00703
• Device Sequence Number: 1
• Product Code: NQW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: G8530205
• Device Catalogue Number: G8530205
• Device Lot Number: W745281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2021
• Initial Date FDA Received: 05/27/2021
• Date Device Manufactured: 09/23/2020
• 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): Other