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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES, USA ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES, USA ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Pain (1994); Discomfort (2330); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
This report is for 8 unknown screw devices. Concomitant medical product: ti collar with groves - item number 498. 011 lot number unknown, quantity 11ea. Ti parallel connector 6. 0mm/6. 0mm - item number 498. 160-lot number unknown, quantity 2 ea. Ti nut 11mm width across flats -item number 498. 003-lot number unknown, quantity 11 ea. Screw - item number unknown, lot number unknown, quantity 3 ea. Therapy date ¿ unknown. This report is for 8 unknown uss screws of unknown sizes. Device is not expected to be returned. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device 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
Patient reported delayed healing, pain and discomfort due to broken rods, which required a revision surgery. The patient had posterior spinal hardware from c2-ilium. The posterior cervical hardware that was implanted was synapse and was connected to the thoracic hardware to the universal spine system (uss) with synapse parallel connectors. The lumbar hardware (uss) was connected to the thoracic hardware with a parallel connector. Basically there is a cervical construct connected to the thoracic uss construct, and the lumbar uss construct connected to the thoracic construct with connectors. The dates of original implantation of the hardware are unknown. The original part numbers of the hardware are unknown. Patient underwent revision surgery on (b)(6) 2016. The patient had broken rods in the lumbar area. The rods were broken on the right side between the s1 and iliac screws. The rods on the left were broken in two places between l2-l3 and l4-l 5 screws. Neither of the part and lot number on the rods was legible. The revision surgery involved only the lumbar construct. Surgeon loosened the parallel connectors that were placed just above t12. Surgeon then removed these rods and then replaced eight of the eleven screws that were implanted from t12-ilium. It is unknown which screws were removed and replaced. After replacing the eight screws that were loose, surgeon contoured new rods. He then placed the new rods in the parallel connectors placed just above the t12 screws. He then connected the rods to the screws. The procedure was successfully completed and patient is reported in stable condition. Concomitant devices: ti collar with groves - item number 498. 011 lot number unknown, quantity 11ea. Ti parallel connector 6. 0mm/6. 0mm - item number 498. 160-lot number unknown, quantity 2 ea. Ti nut 11mm width across flats -item number 498. 003-lot number unknown, quantity 11 ea. Screw - item number unknown, lot number unknown, quantity 3 ea. This is report 2 of 2 for (b)(4).
 
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Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
SYNTHES, USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5933696
MDR Text Key54140285
Report Number2520274-2016-14458
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/07/2016 Patient Sequence Number: 1
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