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

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.

Manufacturer Narrative

There was no product at hand.The manufacturing documents have been checked and found to be according to specification valid during the time production.There are no further complaints with this lot at hand.The root causes for the problem is most probably usage related.According to the case description, the product itself is not defective.Caused by a handling failure, another product (cage) was damaged.A definitive root cause cannot be determined.No capa is necessary.

• Brand Name: ENNOVATE POLYAX.SCREW 7.5X45MM CANULATED
• Type of Device: BONE SCREW FOR POSTERIOR STABILIZATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8142104
• MDR Text Key: 130048478
• Report Number: 9610612-2018-00563
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health 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 Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SY644TS
• Device Catalogue Number: SY644TS
• Device Lot Number: 52443418
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/07/2018
• Device Age: 4 MO
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SY001TS, ENNOVATE SET SCREW STERILE; SY645TS, ENNOVATE POLYAX.SCREW 7.5X50MM CANULATED; SZ370, ENNOVATE MIS K-WIRE NITINOL SHORT
• Patient Outcome(s): Other