MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS CANN POLY SCW 6X45MM,TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186715645
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 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 on an unknown date, patient was in an accident in (b)(6) and taken to a swiss trauma center for a t12 compression fracture.Patient was instrumented percutaneously from t10-l2 using dss viper system last (b)(6) 2019.Upon return to the us, patient was bending and heard/felt a pop.He came to the er and images revealed the hardware had disassembled.Several set screws were displaced and the rod had come out of the screw saddle.During the revision surgery, on (b)(6) 2019, it was found that all of the set screws were loose and some were sitting extremely proud in the screw saddle.Hardware was removed, replaced, and sufficiently locked.There was a hardware failure and infection.There was a patient consequence.Procedure outcome is unknown.Concomitant device reported: viper2 straight rod-160mm (part# 186789160, lot# unknown, quantity 1), viper2 straight rod-180mm (part# 186789180, lot# unknown, quantity 1).This complaint involves sixteen (16) devices.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The screw features signs of use such as surface markings and wear to the drive feature of the screw.However, the screw featured no signs of loosening.No postoperative x-rays were provided to confirm the pedicle screw loosening.The loosening cannot be replicated.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.The root cause of the poly screw loosening postoperatively cannot be determined from the sample and information provided.A potential root cause cannot be determined since the report of the screw loosening could not be confirmed or replicated.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, 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: MIS CANN POLY SCW 6X45MM,TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9152121
• Report Number: 1526439-2019-52197
• Device Sequence Number: 16839673
• Product Code: NKB
• UDI-Device Identifier: 10705034122359
• UDI-Public: (01)10705034122359
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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 Model Number: 186715645
• Device Catalogue Number: 186715645
• Device Lot Number: 121927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention