MAUDE Adverse Event Report: AESCULAP AG ENNOVATE CURVED ROD 5.5X45MM; IMPLANTS POSTERIOR STABILISATI

Model Number SY433TS

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Paresis (1998); Patient Problem/Medical Problem (2688)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation: no product at hand.Batch history review: because the problem is not product related, a batch history review is not necessary.Conclusion and root cause: the root cause of the problem is most probably usage and/or patient related.If additional information is received a follow up report will be submitted.

Event Description

It was reported foot extensor paresis 4 weeks post operatively.The reporter indicated on (b)(6) 2019 the patient came to the outpatient hospital due to increasing right foot extensor paresis 4 weeks postoperatively.The patient was admitted for further neurological intervention, mrt and ct scan.The results of the mrt and ct showed no evidence of a herniated disc or screw failure.Additional information has been requested, however, not yet received.Associated medwatches: 9610612-2019-00239, 9610612-2019-00240, 9610612-2019-00241, (this report), 9610612-2019-00243, 9610612-2019-00244.

• Brand Name: ENNOVATE CURVED ROD 5.5X45MM
• Type of Device: IMPLANTS POSTERIOR STABILISATI
• 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: 8541156
• MDR Text Key: 142799593
• Report Number: 9610612-2019-00242
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SY433TS
• Device Catalogue Number: SY433TS
• Device Lot Number: 52472538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/01/2019
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention