MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 EXP VERSE FENESTRATED SCREW 7.0 X 65; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199723765

Device Problem Torn Material (3024)

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

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One (1) verse 5.5 fenestrated 7x65mm polyaxial screw [product code: 1997-23-765] was returned to chu for evaluation.Visual examination revealed that the threads on the tulip head had become torn.Such damage is indicative of a setscrew being cross threaded and unexpectedly high amounts of force being placed on the threads resulting in them being 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.No emerging trends were found requiring further actions.A definitive root cause for the tulip head threads becoming torn cannot be positively determined.However, noted damage suggests that a setscrew was likely not properly seated during insertion and inadvertently cross threading occurred placing unexpectedly high amounts of force on the threads resulting in torn threads.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.

Event Description

Feedback from surgeon: by now i have done 5 operations with the expedium verse implants.Four out of 5 were deformity surgery.The last case i have done was on (b)(6) this week.The case: (b)(6), male patient with severe cerebral palsy (gmfcs- level 5) w/ a 120° neurogenic thoraco-lumbar scoliosis with shoulder and pelvis obliquity.Aim of surgery: improve sitting and nursing of the patient.Surgery: correction spondylodesis t2-ilium.Problem with the implants: in the scoliosis cases with no severe curves (<60-70°) the implants work pretty well , because they do not get stressed specially the screw head is not stressed! but in severe cases (more than 80-90° and severe rotation of the vertebra) the screw heads seem to have more space in the verse quick stick sleeve and the verse quick stick tube , the verse facilitator and the flex clip reducer and that¿s why the blocker (flate screws, correction screws ) do no run correctly in the screw head and cant.The screw head extension is may be too soft, the diameter of the reichel sleeve, the tube etc.May be too wide.

• Brand Name: 5.5 EXP VERSE FENESTRATED SCREW 7.0 X 65
• 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; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6120945
• MDR Text Key: 60692505
• Report Number: 1526439-2016-10873
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142185
• 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: 09/29/2016

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: 199723765
• Device Lot Number: AVDD77
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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 Age: 21 YR