MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179762480

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: osh, mnh, kwp, mni, and kwq.The device has been 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient¿s rod broke post-op.The patient received the implants in (b)(6) 2020.The patient underwent a revision surgery due to pain on (b)(6) 2021.A broken rod was found on the left side of the construct and at the top of the construct, on the right side, a dislodged screw from l1 was found.Both the rod and screw were replaced in the revision surgery.This report involves one (1) expedium spine system rod 5.5 x 480mm.This is report 2 of 2 for (b)(4).

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.H10 additional narrative: investigation summary.Investigation flow: damage.Visual inspection: the rod, 480 mm (part #: 179762480, lot #: bdns4tw) was received at us cq.Upon visual inspection, the rod was broken and two pieces of the broken device were returned.Scratches were also observed on both broken pieces.Device failure/defect identified? yes.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes investigation conclusion: this complaint is confirmed as the rod was returned broken and scratches were observed on the surface of the broken rod fragments.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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 on the investigation findings, it has been determined that no corrective and/or preventive 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 : bdns4tw.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 23.10.2019.Qty: (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.

• Brand Name: EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM
• 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: 12376954
• MDR Text Key: 268448082
• Report Number: 1526439-2021-01789
• 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
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• 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: BDNS4TW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 09/01/2021
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE UNITIZED SET SCR; UNKNOWN SCREWS; 5.5 EXP VERSE UNITIZED SET SCR; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 95