MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179702000

Device Problem Device Slipped (1584)

Patient Problems Injury (2348); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient was treated with an instrumentation from th11 to l1 with uss mis few years ago.On (b)(6) 2020 the instrumentation was continued from l2 to s1.On (b)(6) 2020 the patient fell while exiting the hospital bed.X-rays taken revealed that both expedium rods have been dislocated.Furthermore it was suspected that both expedium innies in s1 had come loose.The revision surgery was performed on september 8, 2020 and innies at l4/l5 and s1 were removed from both sides of the rods and replaced.The same rod was used.The 6.0 screws in s1 were replaced with 7.0 screws.It is unknown if 2x viper cfx 6,0, or 2x viper 6,0 have been removed.Patient outcome is reported as stable.Concomitant device reported: viper cfx 6.0 (part# unknown, lot# unknown, quantity 2); viper 6.0 (part# unknown, lot# unknown, quantity 2); single innie inserter (part# 279702000, lot# unknown, quantity unknown); single-inner setscrew (part # 179702000, lot # avcffh, quantity 3); single-inner setscrew (part # 179702000, lot # 257617, quantity 1); single-inner setscrew (part # 179702000, lot # unknown, quantity 1); expedium 5.5 ti z-rod 300mm (part # 179798300, lot # ti0884, quantity 1), rod (part # unknown, lot # unknown, quantity 1).This report is for one (1) single-inner setscrew.This is report 6 of 8 for complaint (b)(4).

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.H6: updated codes.Health effect-clinical code is captured by e2402.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.

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: d1, d4: updated (brand name, catalog # and udi #).H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

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.H3, h6: a product investigation was conducted.Visual inspection: mis single inner setscw (part# 186715000, lot# unknown, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the threads of the screw got slightly stripped.The internal drive feature of the screw got damaged.These damages might have occurred during explantation.The part and lot numbers etched on the device are faded and illegible.Functional test: functional testing of the received device was not performed at cq due to the received damaged condition of the device.Dimensional inspection: dimensional inspection of the received device was performed at cq.The outer diameter of the threaded part of the screw was measured and is within specification as per the relevant drawing.Document/ specification review: the relevant drawing(s) was reviewed: no design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint cannot be confirmed for mis single inner setscw (part# 186715000, lot# unknown, qty# 1) as the reported loose condition cannot be replicated.A definitive root cause could not be determined for the reported problem.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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.Mre was not performed as the lot number is not visible on the received device.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: MIS SINGLE INNER SETSCW
• Type of Device: 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: 10613947
• MDR Text Key: 209425134
• Report Number: 1526439-2020-01853
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179702000
• Device Catalogue Number: 186715000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 01/04/2021
• Patient Sequence Number: 1
• Treatment: SINGLE INNIE INSERTER.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; UNKNOWN RODS.; UNKNOWN SCREWS.; UNKNOWN SCREWS.; SINGLE INNIE INSERTER; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention