MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 6.0X45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 199725645S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/23/2020

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 (b)(6) 2020 the patient underwent for a removal surgery due to screw broke off.Generated fragments are remaining in the patient.On (b)(6) 2019 the primary procedure was performed to treat vertebral body fracture.The surgery was completed without delay.The patient outcome was unknown.This complaint involves one (1) device.This report involves one (1) 5.5 exp verse can scr 6.0x45.This report is 1 of 1 for (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.Investigation summary: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual review of the returned device revealed that the screw implant was broken at the proximal end of the quad helix threads.The broken screw piece was not received at us cq.The dimensional inspection of the received device was not performed due to the post-manufacturing damage.The cause for the breakage could not be identified based on the available information.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified as part of depuy spine¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as visual inspection of the received device confirmed the broken condition.No definitive root cause can be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Document/specification review; the drawing reflecting the current and manufactured revision was reviewed.Device history lot: product code: 199725645s, lot number: 219214.The dhr of product code: 199725645s, lot: 219214 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on 08.11.2018, 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: 5.5 EXP VERSE CAN SCR 6.0X45
• 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: 11204341
• MDR Text Key: 227869542
• Report Number: 1526439-2021-00170
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725645S
• Device Lot Number: 219214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 02/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR