MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SINGLE INNER POLYAXIAL SCREW 5.5 X 7.00 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179712745

Device Problem Torn Material (3024)

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

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon implanted the concorde cage at l5.As he was impacting the cage, it shattered.He pulled fragments all fragment out.Left the remaining cage in disc space.Patient was not harmed.Set screw got cross threaded.This in turn ruined the threads in the set screw and pedicle screw.

Manufacturer Narrative

(b)(4).One (1) expedium top loading shank 7x45mm polyaxial screw [product code: 1797-12-745] was also returned to the cqu for evaluation.Visual examination revealed that the initial thread on the tulip head of the polyaxial screw had become torn.Observed damage suggests that inadvertently cross threading occurred between the setscrew and the tulip head threads upon insertion resulting in torn threads.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 for the tulip head threads becoming torn cannot be positively determined.However, the observed damage suggests that inadvertently cross threading occurred between the setscrew and the tulip head threads upon insertion 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.

• Brand Name: SINGLE INNER POLYAXIAL SCREW 5.5 X 7.00 X 45MM
• 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: 6459114
• MDR Text Key: 71689886
• Report Number: 1526439-2017-10228
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

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: 179712745
• Device Lot Number: 118725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1