MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

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.Pma/ g4-510k: this report is for an unknown screw/unknown lot.Potential part numbers reported as 199721640 (qty 2), 199721545 (qty 1), 199721425 (qty 2), 199721550 (2) and 199721001 (2); however it is unknown which screws were loose postoperatively, therefore the loose screw is reported as unknown screw.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that the patient had injuries sustained as a result of titanium rods breakage which were surgically implanted in her back.It was noted that the breakage of the rod was discovered on or about (b)(6) 2020.It was further reported that on (b)(6) 2020 the patient underwent revision posterior spinal fusion with instrumentation, t11-l3, removal of spinal instrumentation, t11-l2, with addition of pedicle screws at l3, and extension of fusion l2-l3, l1 corpectomy and expandable cage reconstruction due to late complications of spinal nonunion at the t12-l1 level, with subsequent fracture of the rods and thoracolumbar junction kyphosis.This was associated with severe pain.Based on operative notes the l1 screws were removed, these were loose.The l2 screws were removed bilaterally, the left screw was loose.The t11 and t12 screws were checked and these were well fixed.The patient suffered a motor vehicle accident resulted in an l1 burst fracture which was unstable, with severe compression of the spinal nerves at the thoracolumbar junction, with resultant permanent neurologic deficits.On (b)(6) 2019 the patient underwent emergent decompression and posterior spinal fusion with instrumentation, t11-l2 and lumbar laminectomy l1.This report is for one (1) unknown screw.This is report 4 of 5 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3 h6 the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo was not able to confirm the reported allegation.Based on the provided evidence it is not possible to confirm a loose condition of the screws.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was unconfirmed for unk screws.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history (lot) a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.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.

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.Updated medications 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.

• Brand Name: UNKNOWN SCREWS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 16461379
• MDR Text Key: 310448301
• Report Number: 1526439-2023-00395
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 4.35 X 25; 5.5 EXP VERSE SCREW 4.35 X 25; 5.5 EXP VERSE SCREW 4.35 X 25; 5.5 EXP VERSE SCREW 4.35 X 25; 5.5 EXP VERSE SCREW 5.0 X 45; 5.5 EXP VERSE SCREW 5.0 X 50; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; UNKNOWN RODS
• Patient Outcome(s): Required Intervention
• Patient Sex: Female