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

Catalog Number 199721000S

Device Problem Torn Material (3024)

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

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation will be conducted.A 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

On (b)(6) 2017, surgery for lumbar canal stenosis was performed using the expedium verse system.The fixed area was t8 - sai.During the surgery, correction key (part#: 199721000s, lot#: unk) got stripped at the time of its final tightening.The surgeon dealt with this event by replacing the reported correction key with a new one.The surgery was successfully completed with a one-minute delay, and there was no adverse consequence to the patient.

Manufacturer Narrative

Visual examination of the returned device found the threads were peeled and torn.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.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause cannot be positively determined.However, based on the visual evaluation, the possible cause can be attributed to not properly seated during insertion and inadvertently cross threading occurred.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 were found, 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 VERSE
• 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: 6889721
• MDR Text Key: 87192583
• Report Number: 1526439-2017-10748
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466125
• UDI-Public: (01)10705034466125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111136
• 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: 08/28/2017

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 Catalogue Number: 199721000S
• Device Lot Number: 109029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/25/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1