MAUDE Adverse Event Report: Synthes GmbH Zero-P; Intervertebral fusion device with integrated fixation, cervical

Catalog Number	03.647.963
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while the implant was mounted on the implant holder, the holder was squeezed, according to the surgical technique.Then the knurled nut was turned on the thread to fix the position of the holder.Shortly before the nut was at the end position, it stopped turning and was jammed.It could no longer be loosened by hand.It did not come loose even with a clamp or forceps.A new implant had to be unpacked, which was then implanted with a clamp.The surgery could be completed successfully with a ten (10) minute delay and no harm to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.  h11 additional narrative:   h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H6: the product was not returned to depuy synthes; however, photos were provided for review.The device associated with this report was not returned to depuy synthes for evaluation.The photographs attached were reviewed, however in the images provided no observations pertaining to the nature of the reported event could be identified as the evidence provided was not sufficient to confirm the reported event of (unable to disassemble).Functionality and device interaction issues cannot be evaluated through photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs attached don¿t have any evidence to draw a conclusion about the reported event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : part number: 04.647.225s lot number: 11951p0 product code: n/a date of manufacture: unknown manufacturing location: unknown part expiration date: n/a nonconformance noted: n/a dhr record review: part/lot combination are unknown at site (b)(4), no manufacturing record evaluation possible.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: Zero-P
• Common Device Name: Intervertebral fusion device with integrated fixation, cervical
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Monument; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50899830
• Report Number: 8030965-2026-09795
• Device Sequence Number: 20333881
• Product Code: OVE
• UDI-Device Identifier: 07611819404458
• UDI-Public: (01)07611819404458(10)31115P8
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.647.963
• Device Lot Number: 31115P8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown