MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 6X45MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	186731645
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from depuy synthes reports an event in japan as follows: it was reported that this was a tlif (l5) for spinal stenosis on (b)(6) 2015.After surgery, an examination on (b)(6) 2017 revealed the breakage of the 2 screws in l5.The cage (t-pal) was also found to be backed out about 10 mm, but the patient was under observation for lack of symptoms.The patient was currently symptom free but had back pain.On (b)(6) 2023, a removal surgery was performed at the patient's request.The tips of the broken screws were remained in the patient¿s body.No further information is available.This complaint involves three (3) devices.This report is for one (1) 5.5 ti cort fix 6x45mm.This is report 2 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint #(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.D2b: additional device product codes: kwp, mni, nkb, kwq.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: state: (b)(6).E3: reporter is a j&j sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.H3/h6: device history lot, product code:186731645, lot no: arnccj.Update by (b)(4) on 23 may 2023 - the lot # arnccj does not exist in sap p02.Dhr review cannot be completed.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: 5.5 TI CORT FIX 6X45MM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL 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 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17043493
• Report Number: 1526439-2023-00962
• Device Sequence Number: 15649434
• Product Code: MNH
• UDI-Device Identifier: 10705034351834
• UDI-Public: (01)10705034351834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 186731645
• Device Catalogue Number: 186731645
• Device Lot Number: ARNCCJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 5.5 TI CORT FIX 6X45MM; UNKNOWN CAGE/SPACER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown