MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 7.0 X 40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199721740
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional narrative: additional product code : kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition(s) of damaged threads was confirmed as the image(s) provided showed threads had broken off from the rest of the implant(s).As the implant(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history review, a manufacturing record evaluation could not be performed as the lot number could not be determined from the image.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for surgery.During the surgery, when attempting final tightening which was not possible due to the damage.The ck damaged the thread on the pedicle screws whilst.It was on the apex of an acute adult degen curve with 3 alifs already in place.The procedure was successfully completed with delay.The patient was good.Concomitant device reported: unknown tightener (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) 5.5 exp verse screw 7.0 x 40.This report is 1 of 2 (b)(4).

• Brand Name: 5.5 EXP VERSE SCREW 7.0 X 40
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11667252
• Report Number: 1526439-2021-00723
• Device Sequence Number: 3128478
• Product Code: NKB
• UDI-Device Identifier: 10705034442112
• UDI-Public: 10705034442112
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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 Model Number: 199721740
• Device Catalogue Number: 199721740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1