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

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).

• Type of Device: ORTHOSIS, 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 Key: 5933696
• MDR Text Key: 54140285
• Report Number: 2520274-2016-14458
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• 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 Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 102