MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM

Catalog Number	03.52.322
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 july 2023: lot 2127950: 70 items manufactured and released on 08-feb-2022.Expiration date: 2027-01-19.No anomalies found related to the problem.To date, 48 items of the same lot have been sold without any similar reported event during the period of review.Additional info received batch review performed on 10 july 2023: pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x40mm (k141988) lot 2229810: 100 items manufactured and released on 25-jan-2023.Expiration date: 2028-01-08.No anomalies found related to the problem.To date, 59 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
L4/5 plif primary surgery was conducted with competitor's products in 2013.During revision surgery of competitor's implant (5.5mm screws) due to adjacent intervertebral obstruction, after insertion of 6x35mm screw in left side and 6x40mm screw in right side, patient's vertebrae fracture was noticed.Both of screws in right and left side were removed.The cause of fracture was unknown.6mm tapping was performed in l5 right and left.The surgeon tried to insert new 6x30mm screw in l5 right side, but the bleeding occurred and the screw was removed.No screw was implanted in both side of l5, a rod was implanted between l3/4 only and the surgery was completed successfully.
Additional Manufacturer Narrative
On the 3rd of august, 2023 we have received the items involved in the event.Visual inspection performed by r&d manager: as reported in additional information received, tapping was performed using ref (b)(4).These taps have an outer nominal diameter of 5 and 6mm, respectively.The actual diameter is undersized -0.5mm for both taps, leading it to ø4.5 and ø5.5mm.The marking on the taps clearly indicates the undersizing and the amount; for ref.(b)(4), for example, it is marked: "tap ø6 mm - undersized 0.5 mm".This confirms the statement reported in the event description:".The diameter of the hole created by 6mm tapping is slightly smaller than 6mm, so the hole will be widened with a screw." ø5.5 screw is not available in must 2 lead portfolio, but only for must mc 4 lead screw.
Event or Problem Description
L4/5 plif primary surgery was conducted with competitor's products in 2013.During revision surgery of competitor's implant (5.5mm screws) due to adjacement intervertebral obstruction, after insertion of 6x35mm screw in left side and 6x40mm screw in right side, patient's vertebrae fracture was noticed.Both of screws in right and left side were removed.The cause of fracture was unknown.6 mm tapping was performed in l5 right and left.The taps used in the surgery were ref.03.51.10.0239 and 03.51.10.0240.The diameter of the hole created by 6mm tapping is slightly smaller than 6mm, so the hole will be widened with a screw.The surgeon tried to insert new 6x30mm screw in l5 right side, but the bleeding occurred and the screw was removed.No screw was implanted in both side of l5, a rod was implanted between l3/4 only and the surgery was completed successfully.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17403723
• Report Number: 3005180920-2023-00564
• Device Sequence Number: 18015792
• Product Code: NKB
• UDI-Device Identifier: 07630030857577
• UDI-Public: 07630030857577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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 Catalogue Number: 03.52.322
• Device Lot Number: 2127950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian