MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number G6956420

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Other: bone fracture.Pma/510k: this product is not approved for sale in us but a similar device with catalog# 6958720, 510k# k143471 and udi (b)(4) is approved for sale in us.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with c1-c2 subluxation; and underwent cervical posterior fixation from occipital bone to c4 for atlantoaxial subluxation.Spinal levels oc-c2-c3-c4 were treated.Intra-op, the screw on the right side of c4 broke the bone.The lateral mass was broken; furthermore, the screw deviated to the lateral side.Hence, this screw was removed from the patient.There was a possibility that the event might have been caused by the 'unreasonable' screw arrangement during rod placement.The position of the plate placed on the occipital bone was too low.Significant differences occurred with the position of the c2 intra lamina screw.There was a considerable difference in the position of the lateral mass screw below shaft and c2.Overall rod alignment became difficult.Since the alignment of the rod changed, the length of the lateral connector (16mm) was not enough, and it was replaced with the connector of 19mm.There was a delay of less than 60 minutes in overall procedure time as a result of this event.No patient complications have been reported as a result of this event.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9959184
• MDR Text Key: 188476608
• Report Number: 1030489-2020-00456
• Device Sequence Number: 1
• Product Code: KWP
• 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: Physician
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G6956420
• Device Lot Number: H5510846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2019
• 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