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

Catalog Number G6956432

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 03/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that on (b)(6) 2011, patient underwent an unknown surgery.On (b)(6) 2017, patient presented with pre-op diagnosis: recurrence of cervical spinal disc herniation.For which patient's fixation range was extended after fixation at levels c6/7.Reportedly, intra-op, during revision surgery, pedicle screws inserted using o-arm and navi deviated.Also, biceps reaction was only 20 % during and immediately after the surgery but it is unknown if it happened due to the screw deviation.The surgeon placed a double spine firmly on c4/5 spinous process.The procedure was performed in this order (c5 left, c4 left, c5 right and c4 right).Creating pilot holes seemed difficult and the surgeon tried it over and over.The surgeon felt something wrong because the double spine also deviated (but why the double spine deviated was unknown at that point).After pedicle screw's insertion, o-arm image revealed that three out of four screws deviated.The surgeon remembered the order of insertion and there was no problem with the c5 left screw so it was judged that pedicle screws started deviating after the c5 left screw insertion.The double spine was confirmed and it was found to be loosened at this point.The surgeon tightened the double spine firmly and images were taken by o-arm again then pedicle screws were reinserted.Surgeon considers that biceps reaction fell because of worsening foraminal stenosis when the screw was inserted, rather than because of the screws deviation.Replacement and reinsertion of screws were performed as a result of this event.There was a delay of more than 60 min in overall procedure time as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6452498
• MDR Text Key: 71461171
• Report Number: 1030489-2017-00722
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/08/2017

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 Catalogue Number: G6956432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 04/02/2017
• Supplement Dates Manufacturer Received: 03/08/2017
• Supplement Dates FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 66 YR
• Patient Weight: 81