MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X45MM CANULATED; POSTERIOR STABILISATION

Model Number SY634TS

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation - no product at hand.Batch history review - the manufacturing documents have been checked and found to be according to specifications valid during the time of production.There are no further complaints with this lot and error pattern at hand.Conclusion and root cause - the root cause is most probably usage and/or patient related.Rationale - with the lack of information and without any product available for analysis, a definitive root cause cannot be determined.In the information the possibility of bad bone structure was mentioned.This could be a possible root cause for the problem.Another possible root cause is a high force used during the implantation of the implants.

Event Description

It was reported that there was postoperative loosening of screws.On (b)(6) 2018, the patient underwent initial spinal surgery and implantation of ennovate screws, set screws, a rod, and tspace peek implants.It was felt that loosening of the screws may have occurred during application with the compression forceps due to insufficient bone structure.A revision was performed for loosening on (b)(6) 2018.There was replacement of screws in the lumbar spinal body 3 and sacral vertebrae; two larger screws (8.5mm instead of 7.5mm) were placed the sacral vertebrae 1, bilateral.There was revision of screws in the lumbar spinal body 4/5, corpectomy of lumbar spinal body 4/5, vertebral body replacement, and cement augmentation at height of lumbar spinal body 3 left side.Further details were not provided.This report addresses the ennovate polyaxial screw (3 of 3), 6.5mm cannulated.Associated medwatches: 9610612-2018-00578; 9610612-2018-00616; 9610612-2018-00579; 9610612-2018-00580; 9610612-2018-00617.

• Brand Name: ENNOVATE POLYAX.SCREW 6.5X45MM CANULATED
• Type of Device: POSTERIOR STABILISATION
• 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 Key: 8191709
• MDR Text Key: 131302845
• Report Number: 9610612-2018-00618
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SY634TS
• Device Catalogue Number: SY634TS
• Device Lot Number: 52384418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/07/2018
• Device Age: 11 MO
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR