MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179797040

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the findings.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In (b)(6) 2017, the patient has had a minimally invasive surgery with expedium viper.The construct included 18 screws inserted from t11 to pelvis, 2 open iliac connectors of 40mm, 1 cocro rod of 480mm cut by half for each of the sides and 20 innies.A revision surgery has been performed today because the rod on the left hand side of the patient had slided.One screw had no rod in its head anymore.The lordosis was not identical anymore on the two sides either.The patient also seemingly reported discomfort.During the revision surgery, all set screws have been removed.The surgeons have reported that on the left hand side, the set screws were loose from l3 to pelvis and on the right hand side, they were loose from l2 to pelvis.A very tiny portion of one set screw thread was found broken while removing the set screws.In addition, surgeons couldn't replace the innie of the iliac connector on the left hand side, as it was not holding properly anymore.They found out that the head of the connector had widened and due to the deformation, the set screw was not sitting in properly anymore.They have therefore decided to replace both iliac connectors too.Finally, they've replaced the 480mm cocro rod by a 480mm titanium rod.

Manufacturer Narrative

Udi: (b)(4).One 5.5 ti open iliac 40mm connector (product code: 1797-97-040, lot number: tbpsb) was returned to the customer quality unit for evaluation on november 16, 2017.Inspection of the tulip head for the connector found significant signs of abrasion and cuts to the side of the threads.The damage travels vertically down the threads towards the base of the tulip head.Typically, damage to the thread happens horizontally, as a cross threaded set screw placed force on a section of thread as it is tightened into the tulip head.It is unknown how this damage may have occurred, though the irregular damage implicates tool usage.The forces placed on the tulip heads may have damaged and bent them sufficiently that they could not readily accept another set screw.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.The root cause of the tulip head's threads being torn cannot be determined from the sample and the information provided.A potential root cause may be tool use during the revision surgery, also resulting in the connector becoming sufficiently warped that it could not fit another set screw.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7009070
• MDR Text Key: 92481219
• Report Number: 1526439-2017-10954
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034082929
• UDI-Public: (01)10705034082929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 179797040
• Device Catalogue Number: 179797040
• Device Lot Number: TBPSB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR