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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI OCCIPITAL SCREW 12MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
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SYNTHES GMBH 4.5MM TI OCCIPITAL SCREW 12MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION Back to Search Results
Catalog Number 04.601.112S
Device Problem Mechanical Problem (1384)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Additional device product codes: mni, mnh, and kwp.Complainant part is not expected to be returned for manufacturer review/investigation.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.(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 that on an unknown date, a patient¿s rod broke, and a screw was loose.In (b)(6) 2018 a posterior cervical fusion was performed on the patient at o-c4.On an unknown date, the patient turned over in bed and heard cracking noise from the cervical area.On (b)(6) 2021 the patient went to see the surgeon, and it was found by ct, that the rod had broken off and the screw was loose.The patient has suffered from paralysis in the limbs since the event.On (b)(6) 2021 the patient is scheduled to undergo a revision procedure for rod replacement and screw-application-range extension.The surgeon evaluated the event¿s severity as ¿mild to moderate.¿ this report involves one (1) 4.5mm ti occipital screw 12mm.This is report 4 of 6 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- product complaint #: (b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: sterile article: part: 04.601.112s; lot: l891820; manufacturing site: selzach; supplier: (b)(6); release to warehouse date: 17.May.2018; expiry date: 01.May.2028.Since there is no allegation against packing or sterility, a manufacturing record evaluation was not performed.Non-sterile article: part: 04.601.112; lot: l859324; manufacturing site: mezzovico; release to warehouse date: 13.Apr.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history batch: null.Device history review: null.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
4.5MM TI OCCIPITAL SCREW 12MM
Type of Device
ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11656924
MDR Text Key245154111
Report Number8030965-2021-02826
Device Sequence Number1
Product Code NKG
UDI-Device Identifier07611819957510
UDI-Public(01)07611819957510
Combination Product (y/n)N
PMA/PMN Number
K142838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.601.112S
Device Lot NumberL891820
Was Device Available for Evaluation? No
Date Manufacturer Received04/18/2021
Patient Sequence Number1
Treatment
CANCELLOUSSCR SYNAPSE Ø3.5 L24 F/R Ø4 TA.; CANCELLOUSSCR SYNAPSE Ø3.5 L28 F/R Ø4 TA.; OCCIPIT-SCR Ø4.5 L14 TAN.; OCCIPIT-SCR Ø4.5 L18 TAN.; OCCIPIT-SCR Ø4.5 L4 TAN.; CANCELLOUSSCR SYNAPSE Ø3.5 L24 F/R Ø4 TA; CANCELLOUSSCR SYNAPSE Ø3.5 L28 F/R Ø4 TA; OCCIPIT-SCR Ø4.5 L14 TAN; OCCIPIT-SCR Ø4.5 L18 TAN; OCCIPIT-SCR Ø4.5 L4 TAN
Patient Outcome(s) Required Intervention;
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