MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X45MM SOLID; ENNOVATE IMPLANTS

Model Number SY134TS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product ennovate polyax.Screw 6.5x45mm solid.An ennovate pedicle screw system revision surgery occurred due to the patient experiencing a traumatic fall.The fall created a chance fracture of the l-5 level, so the surgeon removed two of the prior screws and re-implanted new screws into the l-4 level.It was noted that the physician was satisfied with the outcome of the revision surgery.A revision surgery was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation result: no product available for analysis.Because the batch is unknown, a batch history review is not possible.The root cause for the problem is most probably patient related.Without further knowledge about the circumstances, we suppose, that the fall of the patient (mentioned in the case description) was the root cause for the implant fracture.A capa is not necessary.

• Brand Name: ENNOVATE POLYAX.SCREW 6.5X45MM SOLID
• Type of Device: ENNOVATE IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9131822
• MDR Text Key: 160450187
• Report Number: 2916714-2019-00083
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY134TS
• Device Catalogue Number: SY134TS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention