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 Migration (4003)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional procode: 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 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.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 (b)(6) 2020, a primary fusion procedure at l1~sai was performed.Verse system was applied to l1/s, and expedium sai was used at sai.On (b)(6) 2021, they found that the rod which was deployed at l1 right had come off the screw¿s head.Additionally, the setscrew had been placed in the screwhead.During the revision procedure, the fusion was extended up to th10 without any issue.No further information is available.This report is for one (1) 5.5 exp verse can scr 6.0x45.This is report 1 of 3 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: d4: update.D10: updated concomitant device reported.H3, h6: the subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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

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: h3, h6: investigation summary.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection and dimensional inspection of the returned device.Visual review of the returned device revealed that no damage or anomalies were observed on the 5.5 exp verse can scr 6.0x45 implant.The dimensional inspection of the received device revealed that the device was conforming to the specifications.As part of depuy spine¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the cannulated screw implant was returned without detectable damage.The alleged migration complaint issue could be attributed to the slightly deformed mating set screw implant.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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.Dimensional inspection: the dimensional inspection was performed.Document/specification review; all relevant drawings are reflecting the current and manufactured revisions were reviewed.Device history lot.The dhr of product code: 199725645s.Lot : 211635.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 09.20.2018.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: 11332289
• MDR Text Key: 231992668
• Report Number: 1526439-2021-00300
• 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,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• 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: 211635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Date Manufacturer Received: 03/18/2021
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE CAN SCR 6.0X45.; 5.5 EXP VERSE UNITIZED SET SCR.; 5.5 EXP VERSE UNITIZED SET SCR.; ROD, 480 MM.; UNKNOWN RODS.; 5.5 EXP VERSE UNITIZED SET SCR; UNKNOWN RODS
• Patient Outcome(s): Required Intervention