MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM SINGLE INNIE SET SCREW 6.35; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	179902000
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H10 additional narrative: b3: event occurred on an unknown date between on (b)(6) 2023.D2: additional procodes: kwq, nkb, osh, mnh, kwp.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10: date of concomitant therapy is on (b)(6) 2023.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and / or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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 on (b)(6) 2023, the patient underwent posterior spinal fusion surgery.After the procedure it was noticed that the rods had dislodged from the screw heads of the pelvic screws.A revision surgery was performed on (b)(6) 2023 for rods pulling out of the screws.The revision procedure was completed successfully with no surgical delay.No further information is available.This report is for an expedium spine system single innie set screw 6.35.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the provided series of radiographs revealed that there was found the exp 635 ti si setscrew loose of the mating device.The allegation of loosening was confirmed.The root cause for this failure mode is not established.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for exp 635 ti si setscrew.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4: lot # added.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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.H10 additional narrative: h3, h4, h6 the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the provided series of radiographs revealed that there was found the exp 635 ti si setscrew loose of the mating device.The allegation of loosening was confirmed.The root cause for this failure mode is not established.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for exp 635 ti si setscrew.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM SPINE SYSTEM SINGLE INNIE SET SCREW 6.35
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17361772
• Report Number: 1526439-2023-01305
• Device Sequence Number: 6079708
• Product Code: MNI
• UDI-Device Identifier: 10705034084664
• UDI-Public: (01)10705034084664
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

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?: No
• Operator of Device: Health Professional
• Device Model Number: 179902000
• Device Catalogue Number: 179902000
• Device Lot Number: 339006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 08/18/2023; 09/06/2023; 10/11/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/23/2023; 09/21/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 635 SS ROD, STRT, 600M (HEX); 635 SS ROD, STRT, 600M (HEX); 635 SS ROD, STRT, 600M (HEX); CONN O/O SD TOP NTCH 6.35X6.35; CONN O/O SD TOP NTCH 6.35X6.35; CONN O/O SD TOP NTCH 6.35X6.35; CONN O/O SD TOP NTCH 6.35X6.35; CONN O/O SD TOP NTCH 6.35X6.35; EXP 6.35 TI POLY 10 X 35MM; EXP 6.35 TI POLY 10 X 35MM; EXP 6.35 TI POLY 7 X 40MM; EXP 6.35 TI POLY 8 X 35MM; EXP 6.35 TI POLY 8 X 35MM; EXP 6.35 TI POLY 9 X 35MM; EXP 635 TI LAT CONN 20 MM; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; PRE-LORD ROD, TI, 65MM; PRE-LORD ROD, TI, 75MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 97 KG