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

Catalog Number G6956418

Device Problem Crack (1135)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/22/2018

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

Pre-operative diagnosis: cervical spondylotic myelopathy due to symptomatic recurrence.Type of procedure: posterior cervical decompression and fusion.It was reported that intra-operatively when the pedical screw was inserted in c7 through ct navigation it was observed with the help of c-arm that it was penetrating the end plate of cranial side at c7 and deviated from pedical screw.Due to which the screw driver slid and touched the dura and injury of the dura occurred.Thereafter additional surgery dural suture was performed, so the screw was removed.While inserting the screw after decompression.A crack occurred in the arch of vertebra.Due to which the screw was not inserted.The surgery was delayed by less than 60 minute due to this event.Both the implants did not come in contact with the patient.No breakage of implants occurred due to reported event.No fragments of instruments were remained in patient.Patient complications were unknown with the available information.During fusion at c2-th1 when inserting the pedical screw at c7 the screw deviated.While confirming the direction with the navigation pointer, at the time of drilling the pilot hole and inserting the screw with a normal instrument, the screw deviated from the pedicle, so it was removed.It was recognized as technical error.Injury to the dura was occurred before inserting the rod, when attempting to insert the left c6 or c7 screw additionally the tip of did not fit in the hex of the screw well and it slid and the dura mater injured, so suture was performed.It was recognized as technical error.The crack of arch of vertebra of c4 drilling the pilot hole decompression 2.7mm tap there was a crack in the vertebral arch when the reported screw was inserted.It was recognized that the event occurred because it was overly shaved during decompression.

• 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: 7624938
• MDR Text Key: 111876943
• Report Number: 1030489-2018-00887
• 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: Other
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G6956418
• Device Lot Number: H5382142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2017
• 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
• Patient Age: 78 YR