MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 480 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179762480

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product code kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on an unknown date that the patient was underwent for an original spinal fusion was performed with expedium system treating kyphoscoliosis on an unknown date.The following issues were found postoperatively on an unknown date.The patient suffered from the 8th thoracic centrum fracture.The rods had broken between s1 and s2 on both sides.On (b)(6) 2020 the patient underwent a revision procedure successfully.The patient outcome was unknown.This complaint involves two (2) devices.This is report 1 of 2 for (b)(4).

Event Description

Updated ed: concomitant device reported: expedium screws 5.5 7 x 50mm (part# 186731750 , lot# unknown, quantity 1).Expedium screws 5.5 7 x 45mm (part# 186731745, lot# unknown, quantity 1).

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: b5: updated event description.D4: updated lot#.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data: h3, h4, h6.Investigation summary: investigation flow: damage.Visual inspection: the rod 480 mm (part #: 179762480, lot #: bdkl6s9) was returned and received at us customer quality (cq).Upon visual inspection, the rod was observed to be broken and the broken fragment was returned to the us cq.No other issues were identified with the returned device.Device failure/defect identified? yes.Document/specification review: based on the date of manufacture the following drawings, the current and manufactured revision of drawings were reviewed: mm si/merlin 5.5 0 mm rod ti, 300/480 mm hex end.Dimensional inspection: the diameter of the rod was measured to be within the specification.Complaint confirmed? yes.The device received was broken, confirming the allegation.Investigation conclusion the complaint condition is confirmed for the rod 480 mm.There is no indication that a design or manufacturing issue has caused the complaint condition.The root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 history lot: the dhr of product code 179762480, lot bdkl6s9, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on july 1st, 2016.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: ROD, 480 MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10102868
• MDR Text Key: 193326671
• Report Number: 1526439-2020-01090
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077437
• UDI-Public: (01)10705034077437
• Combination Product (y/n): N
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179762480
• Device Catalogue Number: 179762480
• Device Lot Number: BDKL6S9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Date Manufacturer Received: 07/06/2020
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X50MM; UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR