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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 199721001S
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 unitized set scr.This is report 2 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.H3, h6: investigation summary: the product was returned to the us cq for evaluation.Us cq conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the set screw implant distal end surface was slightly deformed.The dimensional inspection of the received device revealed that the device was conforming to the specifications.The cause for the deformation could not be identified.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 it was observed that the set screw implant was slightly deformed at the distal end.While no definitive root cause could be determined, it is possible the observed deformation issue would contribute to the alleged rod implant migration issue.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 dimensional inspection: the dimensional inspection was performed.Document/specification review: all relevant drawing are reflecting the current and manufactured revision was reviewed.Device history lot: the dhr of product code: 199721001s, lot : xd1133 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 04.17.2020 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.
 
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Brand Name
5.5 EXP VERSE UNITIZED SET SCR
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key11332468
MDR Text Key232012104
Report Number1526439-2021-00301
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466149
UDI-Public10705034466149
Combination Product (y/n)N
PMA/PMN Number
K142185
Number of Events Reported1
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 Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number199721001S
Device Catalogue Number199721001S
Device Lot NumberXD1133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2021
Date Manufacturer Received03/18/2021
Patient Sequence Number1
Treatment
5.5 EXP VERSE CAN SCR 6.0X45.; 5.5 EXP VERSE CAN SCR 6.0X45.; 5.5 EXP VERSE UNITIZED SET SCR.; ROD, 480 MM.; UNKNOWN RODS.; 5.5 EXP VERSE CAN SCR 6.0X45; UNKNOWN RODS
Patient Outcome(s) Required Intervention;
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