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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CSL-SCR 3 L14 TAN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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OBERDORF SYNTHES PRODUKTIONS GMBH CSL-SCR 3 L14 TAN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 04.617.814
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Unspecified Infection (1930)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Migration/infection has unknown event date is 2019 this report is for an unknown zero-p screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 a revision surgery occurred on (b)(6) 2019 due to two (2) migrated zero p screws.The original zero-p cage and four (4) screws were originally implanted on (b)(6) 2019.The two (2) migrated screws were removed without a screw driver.The screws had completely backed out of the zero p cage.The remaining two (2) screws that were still engaged in the cage were also removed.The zero p cage was left insitu without screw fixation.The patient was then re-positioned in the prone position and posterior lateral mass screws were inserted from c3-7.The surgeon suspected infection and took a wound swab from the anterior cage site.Patient status is unknown.This is report 1 of 5 for (b)(4).This report is for one (1) unknown zero-p screw.
 
Event Description
Signs of infection was noticed on imaging and intraoperatively.This complaint involves six devices.
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: visual inspection: the visual inspection of the returned screws has identified strongly damages overall the threaded part section.One screw shows a cracked thread flank.Also, the stardrive on top of the screws are worn out.All in all, the screws are strongly worn out.Functional test: it is not possible to perform a functional as the threads are in very used condition.Summary: the visual inspection of the returned screws has identified strongly damages overall the threaded part section.One screw shows a cracked thread flank.Also the stardrive on top of the screws are worn out.All in all, the screws are strongly worn out.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use-related damage at the parts.Unfortunately we are not able to determine the exact cause which has led to the problem.Since the threaded part sections on all the screws are strongly damaged we assume that the involved screws were not inserted aligned into the corresponding hole during insertion procedure.By this situation the thread got inevitable damaged which resulted in the malfunction of the device.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data-d1, d4, g2.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
CSL-SCR 3 L14 TAN
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9254668
MDR Text Key180399252
Report Number8030965-2019-69798
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
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 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.617.814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Date Manufacturer Received12/04/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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