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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - MONO/POLYAXIAL SCREW COLLARS/SLEEVES/HEADS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
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SYNTHES GMBH UNK - MONO/POLYAXIAL SCREW COLLARS/SLEEVES/HEADS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION Back to Search Results
Device Problem Compatibility Problem (2960)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2021
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown mono/polyaxial screw collars/sleeves/heads: uss/unknown lot.Part and lot numbers are unknown, udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Initial reporter address line 1: orthotics therapy & dietetics dept ground floor oxford road.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 the (b)(6) as follows: it was reported that on(b)(6), 2021, during pediatric deformity case it was noticed that the poly head screw on t4 (patients left) made a cracking noise during final tightening and would not fully tighten.The nut and sleeve were changed but the poly head screw would not tighten.The ring around the poly head was inspected, and there were no visible cracks.The poly head screw was used, and the case was successfully completed.This report involves one (1) unknown mono/polyaxial screw collars/sleeves/heads: uss.This is report 2 of 2 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.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
Concomitant device reported: unknown pedicle screws (part# unknown; lot# unknown; quantity: unknown).Unknown torque limiting instrument (part# unknown; lot# unknown; quantity: 1).Unknown rods (part# unknown; lot# unknown; quantity: 1).
 
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Brand Name
UNK - MONO/POLYAXIAL SCREW COLLARS/SLEEVES/HEADS: USS
Type of Device
ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11552496
MDR Text Key244653689
Report Number8030965-2021-02201
Device Sequence Number1
Product Code MNH
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
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2021
Patient Sequence Number1
Treatment
UNK - RODS: USS; UNK - RODS: USS; UNK - TORQUE DEVICES; UNK - TORQUE DEVICES; UNKNOWN PEDICLE SCREWS; UNKNOWN PEDICLE SCREWS; UNKNOWN USS POLYAXIAL HEAD; UNKNOWN USS POLYAXIAL HEAD; UNKNOWN USS-II NUT; UNKNOWN USS-II NUT; UNKNOWN USS-II POLYAXIAL SLEEVE; UNKNOWN USS-II POLYAXIAL SLEEVE; USS-II POLYAXIAL 3D-HEAD F/R ÿ6 TAN GREE; USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE
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