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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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DEPUY SYNTHES SPINE EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 186100001
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2017
Event Type  malfunction  
Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with findings.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Surgeon had initially tightened the set screws with standard set screw driver.When going back to final tighten, the set screw did not seem to tighten/seat properly.The surgeon thought the torque driver slipped, but it appeared that the set screw looked broken.After backing out the set screw, it was clear that the part of the threads had broken off in the process of tightening.This occurred on 2 set screws in the construct during final tightening and it is unclear whether anything was cross-threaded or what may have been the problem.
 
Manufacturer Narrative
Udi: (b)(4).One (1) expedium 4.5 ti single innie set screw [product codes: 1861-00-001] was returned to the customer quality unit (cqu) for evaluation.Visual examination revealed that the set screw (lot number illegible) had torn threads.Observed damaged suggests that the threads had become inadvertently cross threaded during insertion resulting in torn threads.A review of the device history record (dhr) for the expedium 4.5 ti single innie set screw could not be conducted.It should also be noted that the set screw had illegible lot number, and as such, the manufacturing records could not be conducted.As lot number is illegible on the surface of the device it is impossible to identify its lot number and perform a manufacturing record search.No emerging trends were found requiring further actions.A definitive root cause for the set screw becoming torn cannot be positively determined.However, observed damaged suggests that the threads had become inadvertently cross threaded during insertion resulting in torn threads.As no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.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
EXPEDIUM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808201
MDR Report Key6952239
MDR Text Key90056378
Report Number1526439-2017-10843
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034103846
UDI-Public(01)10705034103846
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number186100001
Device Catalogue Number186100001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/26/2017
Initial Date FDA Received10/16/2017
Supplement Dates Manufacturer Received10/18/2017
Supplement Dates FDA Received10/19/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Age8 YR
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