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OBERDORF SYNTHES PRODUKTIONS GMBH TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH FOR 4.0MM RODS; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
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| Catalog Number 04.615.601S |
| Device Problems
Break (1069); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown occipital plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Occupation: initial reporter is synthes sales consultant.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.
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Event Description
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Device report from synthes europe reports an event in the (b)(6) as follows: it was reported patient was implanted with an unknown synapse occipital plate on unknown date, reportedly a couple of years ago.On unknown date, patient reported pain.It was further reported patient suffered a fall has been deteriorating.Scans and radiographs were conducted, revealing an occipital plate was broken in situ.A revision procedure is planned but has not yet been scheduled.Concomitant device reported: screw (part unknown, lot unknown, quantity unknown).This report is for one (1) unknown cervical plate.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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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.(b)(4).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.
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Event Description
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This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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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 history records review was completed for part: 04.615.601s, lot: 9536397.Manufacturing location: mezzovico, release to warehouse date: jul 09, 2015, expiry date: jul 01, 2025.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A manufacturing evaluation of the returned part was performed.A visual inspection has been performed and it confirmed that the received condition agrees with the complaint condition but no visual defects manufacturing related have been identified on returned item.The dimensional re-inspection, the raw material certificate review and the document/specification review didn¿t identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.The complaint is confirmed as the plate broke twice and therefore the variable rod attachment bodies were separated, respectively pulled out from the plate.Based on the provided information we are not able to determine the exact cause of this breakage.We can only assume that any occurrence during the healing process, like the in the complaint description mentioned fall, did lead to the failure of the plate.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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.
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Event Description
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It was further reported that revision surgery was completed as planned on (b)(6) 2018.Revision surgery was completed successfully.
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Event Description
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(b)(6) 2019 updated event description: device report from synthes europe reports an event in the united kingdom as follows: it was reported that on an unknown date, patient had been experiencing a lot of pain.The patient had implantation of an occipito-cervical synapse plate (oc synapse) device a couple of years ago.The patient had a fall and has been deteriorating.Scans / radiographs were done and found that the occipito-cervical synapse plate implant had broken in situ.It was unknown if there was surgical delay reported.It was unknown how the surgery was completed.Patient outcome was unknown.Concomitant device reported: occipital screw (part#04.601.110, lot#9955386 , quantity#1) occipital screw (part#04.601.110, lot#8636407, quantity#1) occipital screw (part#4.601.110, lot#unknown, quantity#1) locking cap (part#04.614.508, lot#h682562, quantity#1) locking cap (part#04.614.508, lot#h081462, quantity#1) locking cap (part#04.614.508, lot#unknown, quantity#2) this is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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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.Updated event description and concomitant devices reported.Additional product codes: kwp, mnh, mni reporter updated.Patient code 3191 used to capture: the reported event required medical/surgical intervention to preclude permanent damage to a body structure.The plate broke postoperatively requiring revision surgery.The screws (2) were backed out on x-ray.H3, h6: pd summary; x-rays reviewed by cqcchart team.The failure appears to be the breakage (pull-out) of the screw sub-component of the t-plate.No final conclusion possible as only one x-ray in one plane in poor quality is was received.The risk file of the synapse occipital screws was reviewed and this complaint condition is adequately addressed.Product was not returned and no lot number was provided, therefore no further evaluation is possible.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.H11: d1, d2, d4: updated for reporting.G1 - manufacture location provided for reporting.G5: 510k provided for reporting.Device was used for treatment, not diagnosis.
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