MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X40; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	199723740S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that spinal fixation or spondy grade 2 s1-l5 was performed.Six months after surgery the treating physician noticed that one screw (right side) was broken, and the rod had slipped through the screw head in s1 on left side.Right side the screw was broken and had rotated.Also the rod had slipped through the screw head l5 on this side.All locking caps were tightened according to the surgical technique and double checked during surgery for correct torque locking.The rod slippage and breakage has occurred in the months after the surgery.The surgery itself was successful and no postoperative events have occurred that might explain the screw breakage.The patient was treated for a spondy grade 2 at level s1-l5.Primary surgery date (b)(6) 2017.Patient gender female.Dob (b)(6).No other patient data is available.
Additional Manufacturer Narrative
(b)(4).Device returned for evaluation.Investigation will be conducted.Follow up will be filed with findings.
Additional Manufacturer Narrative
(b)(4).Visual examination at the macroscopic level found that the screw shank had fractured.A fracture analysis was conducted on the returned device.It was noted that the fracture analysis exhibits two surface morphologies, a smooth region and a grainy/rough region with progression lines which are indicative of fatigue failure.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the screw shank fracturing cannot be positively determined.However, the fracture analysis report exhibits two surface morphologies, a smooth region and a grainy/rough region with progression lines which are indicative of fatigue failure.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: 5.5 EXP VERSE FEN SCR 7.0X40
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7756502
• Report Number: 1526439-2018-50746
• Device Sequence Number: 1084588
• Product Code: NKB
• UDI-Device Identifier: 10705034444512
• UDI-Public: (01)10705034444512
• Combination Product (Y/N): N
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 199723740S
• Device Catalogue Number: 199723740S
• Device Lot Number: AVLCW2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 01/07/2019
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/26/2018; 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK RODS
• Outcome Attributed to Adverse Event: Required Intervention