MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LOCK-CLIP PEEK; ZERO-P IMPLANT

Catalog Number 890.005S

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from the (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 the corpectomy gap was measured at 23mm and an expandable corpectomy device (ecd) cage sized 20-27 was chosen.Upon the initial ecd cage insertion the cage was removed to resect a little more bone.While the cage was out of the patient the assisting surgeon over extended the cage with the insertion instrument leading to a grinding noise.The cage then was implanted and locked into place with the locking clip and a supporting vectra plate and 4 screws were implanted over it.Upon checking the surgeon noticed the cage had collapsed.All implants were required to be removed.The vectra plate upon removal was destroyed as the removal screwdriver was not used and the blocking mechanism was torn out of the plate.Another cage was inserted that was slightly larger due to there being only one of each size but the next cage was in the range at 24mm so impact was minimal.The newly opened cage expanded and collapsed well before implantation leading to the confirmation that it wasn¿t the insertion/expansion instrument at fault.The plate and the screws were also exchanged for ones with longer length and larger diameter.Good fixation was achieved.There was a surgical delay of thirty (30) minutes.Concomitant devices: unknown insertion instrument (part # unknown, lot # unknown, quantity unknown), unknown screws (part # unknown, lot # unknown, quantity 4), unknown screwdriver (part # unknown, lot # unknown, quantity unknown).This report is for one lock-clip peek.This is report 2 of 2 for (b)(4).

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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant devices: holding/distraction instrument for ecd (part # 397.127, lot # unknown, quantity 1), cervical spine screws (part # 04.613.516, lot # unknown, quantity 4), screwdriver (part # 324.105, lot # unknown, quantity 1).

• Brand Name: LOCK-CLIP PEEK
• Type of Device: ZERO-P IMPLANT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9512187
• MDR Text Key: 194141376
• Report Number: 8030965-2019-71381
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 07611819893061
• UDI-Public: (01)07611819893061
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 890.005S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS; UNK - SCREWDRIVERS; UNK - SCREWS
• Patient Outcome(s): Required Intervention