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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X45MM CANULATED BONE SCREW FOR POSTERIOR STABILIZATION

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AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X45MM CANULATED BONE SCREW FOR POSTERIOR STABILIZATION Back to Search Results
Model Number SY644TS
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 11/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation is on-going at the manufacturing site. A supplemental report will be submitted when additional information is available.
 
Event Description
It was reported that during a minimally invasive surgery (mis) for the l4-5 and s1, the rod was pressing on the l4 and s1 which resulted in the need for force to be applied in order to place the rod in the screw head at l5. X-ray taken after the procedure indicated that the screw was slightly pulled out of the vertebral body. The surgeon would have had to turn the screw back in order to gain more height, but he finished the operation and fixed all components. During a follow up appointment, breakage of l5 was noted (cleavage fracture). The surgeon has stated that it appears that the force transmission during rod pressing is so strong that a fracture can occur. This is the first time he has seen this. The patient must be revised to for decompression of the neuroforamen. Patient consequence: decompression of the spinal canal; pain after surgery implants are still implanted at the date of this report. No information is available regarding scheduling of revision surgery. Involved components listed as concomitant devices include: sy937ts, ennovate mis curved rod 5. 5x70mm, 52415155; sy645ts, ennovate polyax. Screw 7. 5x50mm canulated, 52445955; sy645ts, ennovate polyax. Screw 7. 5x50mm canulated, 52413487; sy645ts, ennovate polyax. Screw 7. 5x50mm canulated, 52389890; sy001ts, ennovate set screw sterile, 52406268; sy001ts, ennovate set screw sterile, 52382956; sy001ts, ennovate set screw sterile, 52406268; sz370, ennovate mis k-wire nitinol short, unknown.
 
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Brand NameENNOVATE POLYAX.SCREW 7.5X45MM CANULATED
Type of DeviceBONE SCREW FOR POSTERIOR STABILIZATION
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8142104
MDR Text Key130048478
Report Number9610612-2018-00563
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K180433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSY644TS
Device Catalogue NumberSY644TS
Device Lot Number52443418
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/07/2018
Device Age4 MO
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/07/2018 Patient Sequence Number: 1
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