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

Model Number 186731645

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/15/2017

Event Type  Injury  

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)(6) 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.

Event 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 1 of 3 for complaint (b)(4).

• Brand Name: 5.5 TI CORT FIX 6X45MM
• Type of Device: 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: 17043601
• MDR Text Key: 316389745
• Report Number: 1526439-2023-00961
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034351834
• UDI-Public: (01)10705034351834
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 6X45MM; UNKNOWN CAGE/SPACER
• Patient Outcome(s): Required Intervention