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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 50MM THRD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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OBERDORF : SYNTHES PRODUKTIONS GMBH 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 50MM THRD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 498.990
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient age, date of birth, and weight not available for reporting.Date of event: unknown.Additional product codes: mnh, mni, kwp, kwq.Date of implant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported patient underwent a procedure on (b)(6) 2018 to remove the 6.2mm preassembled clickx pedicle screw due to the release of the 3d head of the screw.No further information was provided.This report is for one (1) 6.2mm clickx pedicle screw preassembled 50mm.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device manufacture date is now known.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
It was reported the patient underwent a lumbar arthrodesis procedure on (b)(6) 2018.During the procedure, the thread of the pedicle screw broke making it difficult to remove the screw; additional pressure was used for its withdrawal.
 
Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.Dhr review was completed.Part: 498.990.Lot: 8957971.Manufacturing site: mezzovico.Release to warehouse date: 30.Apr.2014.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed and the used material was according to specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.The implant was received with the reported condition of ¿broken (2+ pieces) postoperatively : rm.¿ the following investigation flow was performed: broken.It was visually observed that the screw head, spherical segment and locking cone have broken off from the screw itself.In addition there is damage on the top of the proximal end of the screw and the top four proximal threads showings signs of rolling.The wear on the device indicates it was implant and subsequently removed.The complaint condition is confirmed and the received condition agrees with the complaint description.The cause of the issue could not be definitively traced to use error, misuse/abuse, non-compliance, postoperative trauma.Dimensional inspection was not performed due to post manufacture damage.A device history review, was performed for the returned implant¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.A review of the current design drawing and the drawing revision at the time of manufacture was performed: top level and no issues were identified.Based on the available information it is not possible to determine a definitive root cause for the complaint condition as the circumstances surrounding the complaint are unknown.A material inspection was done during the time of dhr review and it stated: the raw material certificate was reviewed and the used material was according to specification for implants for surgery.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.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
6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 50MM THRD LENGTH
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7589717
MDR Text Key110701207
Report Number2939274-2018-52461
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034792392
UDI-Public(01)10705034792392
Combination Product (y/n)N
PMA/PMN Number
K082572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number498.990
Device Catalogue Number498.99
Device Lot Number8957971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Date Manufacturer Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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