MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANC; SPINE SCREW

Catalog Number	03.30.133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot of the screw broken is not known for this we report the batch review of all the screw implanted.Batch review performed on 02-july-2019: mectalif anterior 03.30.115 mectalif anterior stand-alone screw diam.5.5x25 enhanced (k160605) lot 1621051: (b)(4) items manufactured and released on 18-may-2017.Expiration date: 2022-03-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Mectalif anterior 03.30.133 mectalif anterior stand-alone screw diam.5x35 enhanced (double packaging) (k160605) lot 1621048: (b)(4) items manufactured and released on 18-may-2017.Expiration date: 2022-04-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Mectalif anterior 03.30.133 mectalif anterior stand-alone screw diam.5x35 enhanced (double packaging) (k160605) lot 1621050: (b)(4) items manufactured and released on 27-july-2017.Expiration date: 2022-07-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event mectalif anterior 03.30.131 mectalif anterior stand-alone screw diam.5x25 enhanced (double packaging) (k160605) lot 1621051: (b)(4) items manufactured and released on 01-sep-2017.Expiration date: 2022-07-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event clinical evaluation performed by medacta medical affairs director: approximately 1 year after alif lumbar stabilization, one of the screws sheared off just below the head.This kind of occurrence may intervene when the expected fusion, in this case l5-s1, did not occur.We could not find reports of clinical problems: if hte fusion intervened afterwards it is possible that no intervention is required.The report does not specify how, ong after primary surgery the screw was found to be broken.With the information at hand, we cannot draw any conclusion for the scope of the clinical investigation.
Event or Problem Description
Spine screw breakage after about 1 year and 7 months from primary surgery.No revision surgery has been performed for the moment.The patient had a revision surgery few days after primary to put l5 endplate and to shorten s1 screw sitting in the foramen.The date of primary surgery is unknown for the moment.
Additional Manufacturer Narrative
On the 7 july 2019 we received the date of the primary surgery and more details about the first revision performed few days after primary.On the 23 july 2019 we were informed that there are no evidence of revision surgery performed to this patient.
Event or Problem Description
Spine screw breakage after about 1 year and 7 months from primary surgery.No evidence of revision surgery performed for the moment.The patient had a revision surgery few days after primary to put l5 endplate and to shorten s1 screw sitting in the foramen, the surgeon only swapped out 1 screw as he was unhappy with size he originally used.The primary surgery has been performed on the (b)(6) 2017.

• Brand Name: MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANC
• Common Device Name: SPINE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8764337
• Report Number: 3005180920-2019-00542
• Device Sequence Number: 2473545
• Product Code: OVD
• UDI-Device Identifier: 07630030875434
• UDI-Public: 07630030875434
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K160605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2022
• Device Catalogue Number: 03.30.133
• Device Lot Number: 1621048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention